Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT03027557
Status:
COMPLETED
Last Update Posted:
2021-05-25
First Post:
2017-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Primary Hyperparathyroidism With Denosumab and Cinacalcet.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D049950', 'term': 'Hyperparathyroidism, Primary'}, {'id': 'D010282', 'term': 'Parathyroid Neoplasms'}], 'ancestors': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069449', 'term': 'Cinacalcet'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D000069448', 'term': 'Denosumab'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'p.vestergaard@rn.dk', 'phone': '+45 97 66 36 00', 'title': 'Professor Peter Vestergaard', 'organization': 'Aalborg University Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Important limitations are the relatively small number of study-participants, and the lack of a cinacalcet monotherapy-arm.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for each participant from baseline until two weeks after treatment-cessation, up to 1 year.', 'description': 'Adverse events were collected at each visit using a adverse event questionnaire as well as assessment by a study-physician.', 'eventGroups': [{'id': 'EG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 13, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 15, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Leg edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Coughing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Paraesthesia, hands', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 36, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 15, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 20, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Paraesthesia, feet', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 17, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 27, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 23, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 17, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 18, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 21, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 14, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 17, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 20, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 33, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 20, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Angina, Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Polycythaemia Vera', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Inflammatory Bowel Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Lumbar Spine Bone Mineral Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.030', 'spread': '0.009', 'groupId': 'OG000'}, {'value': '0.042', 'spread': '0.009', 'groupId': 'OG001'}, {'value': '-0.016', 'spread': '0.007', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.00001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,one year', 'description': 'Change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan.', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan.'}, {'type': 'PRIMARY', 'title': 'Change in Total Hip Bone Mineral Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.027', 'spread': '0.006', 'groupId': 'OG000'}, {'value': '0.021', 'spread': '0.003', 'groupId': 'OG001'}, {'value': '-0.013', 'spread': '0.006', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.00001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,one year', 'description': 'Change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan.', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the placebo group did not provide results for this analysis as he/she had had a hip-replacement performed.'}, {'type': 'PRIMARY', 'title': 'Change in Femoral Neck Bone Mineral Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.023', 'spread': '0.006', 'groupId': 'OG000'}, {'value': '0.020', 'spread': '0.005', 'groupId': 'OG001'}, {'value': '-0.007', 'spread': '0.006', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '= 0.0019', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,one year', 'description': 'Change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan.', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the placebo group did not provide results for this analysis as he/she had had a hip-replacement performed.'}, {'type': 'PRIMARY', 'title': 'Change in 1/3 Forearm Bone Mineral Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.005', 'spread': '0.003', 'groupId': 'OG000'}, {'value': '0.005', 'spread': '0.003', 'groupId': 'OG001'}, {'value': '-0.005', 'spread': '0.004', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '= 0.096', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,one year', 'description': 'Change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan.', 'unitOfMeasure': 'g/cm^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the denosumab group did not provide results for this analysis as he/she experienced a wrist fracture prior to the final scan.'}, {'type': 'PRIMARY', 'title': 'Percentage Change in Lumbar Spine Bone Mineral Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '0.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '= 0.0001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,one year', 'description': 'Percentage change of Bone Mineral Density after one year of treatment from baseline.\n\nMeasured with Dual-energy X-ray absorptiometry (DXA)-scan.', 'unitOfMeasure': '% change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan.'}, {'type': 'PRIMARY', 'title': 'Percentage Change in Total Hip Bone Mineral Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.45', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '2.64', 'spread': '0.41', 'groupId': 'OG001'}, {'value': '-1.50', 'spread': '0.72', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.00001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,one year', 'description': 'Percentage change of Bone Mineral Density after one year of treatment from baseline.\n\nMeasured with Dual-energy X-ray absorptiometry (DXA)-scan.', 'unitOfMeasure': '% change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the placebo group did not provide results for this analysis as he/she had had a hip-replacement performed.'}, {'type': 'PRIMARY', 'title': 'Percentage Change in Femoral Neck Bone Mineral Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.70', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '3.03', 'spread': '0.86', 'groupId': 'OG001'}, {'value': '-0.78', 'spread': '0.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '= 0.0027', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,one year', 'description': 'Percentage change of Bone Mineral Density after one year of treatment from baseline.\n\nMeasured with Dual-energy X-ray absorptiometry (DXA)-scan.', 'unitOfMeasure': '% change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the placebo group did not provide results for this analysis as he/she had had a hip-replacement performed.'}, {'type': 'PRIMARY', 'title': 'Percentage Change in 1/3 Forearm Bone Mineral Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.94', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '-0.91', 'spread': '0.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '= 0.081', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,one year', 'description': 'Percentage change of Bone Mineral Density after one year of treatment from baseline.\n\nMeasured with Dual-energy X-ray absorptiometry (DXA)-scan.', 'unitOfMeasure': '% change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the denosumab group did not provide results for this analysis as he/she experienced a wrist fracture prior to the final scan.'}, {'type': 'SECONDARY', 'title': 'Change in Volumetric BMD for the Lumbar Spine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.93', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '5.35', 'spread': '1.91', 'groupId': 'OG001'}, {'value': '-2.56', 'spread': '1.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '= 0.0071', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, one year', 'description': 'Measured at baseline and after one year by QCT.', 'unitOfMeasure': 'mg/cm^3', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. Another scan could not be included due to a technical problems with the image analysis.'}, {'type': 'SECONDARY', 'title': 'Mean P-calcium During Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}, {'units': 'p-calcium measurements', 'counts': [{'value': '210', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '224', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.28', 'spread': '0.007', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '0.006', 'groupId': 'OG001'}, {'value': '1.40', 'spread': '0.004', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '= 0.0001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Monthly up to one year.', 'description': 'Blood samples were acquired once every 4 weeks for safety-purposes.', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'p-calcium measurements', 'denomUnitsSelected': 'p-calcium measurements'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in P-carboxy-terminal Collagen Crosslinks (CTX)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-48.7', 'groupId': 'OG000', 'lowerLimit': '-73.2', 'upperLimit': '-15.8'}, {'value': '-58.2', 'groupId': 'OG001', 'lowerLimit': '-76.7', 'upperLimit': '-44.3'}, {'value': '11.8', 'groupId': 'OG002', 'lowerLimit': '1.96', 'upperLimit': '40.0'}]}]}], 'analyses': [{'pValue': '= 0.0001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Change from baseline at 48 weeks reported.', 'description': 'p-CTX, change from baseline at 48 weeks.', 'unitOfMeasure': '% change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final blood-sampling.'}, {'type': 'SECONDARY', 'title': 'Median Agatstons Score Final', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '78.1'}, {'value': '24.3', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '602.1'}, {'value': '117.8', 'groupId': 'OG002', 'lowerLimit': '6.8', 'upperLimit': '182.6'}]}]}], 'analyses': [{'pValue': '= 0.38', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, one year', 'description': 'Simultaneously with QCT-measurements coronary calcification was be assessed. Agatston score is a score based on the extent of coronary artery calcification calculated on the amount of plaque observed in a CT scan. A score of zero indicates absence of coronary calcium, 1-10: minimal calcification, 11-100 mild calcification, 101-400 moderate calcification, \\>400 severe calcification.\n\nThus the score increases with increasing level of calcification in the coronary vessels.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participant from the combined and placebo groups could not be included in the analysis because they had coronary stents.'}, {'type': 'SECONDARY', 'title': 'Patients With Nephrolithiasis Final Scan.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Patients with nephrolithiasis at one year reported.', 'description': 'Number of subjects w. renal stones at final scan.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final blood-sampling.'}, {'type': 'SECONDARY', 'title': 'Patients With Pancreas-calcifications Final Scan.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Patients with pancreas-calcifications at one year reported.', 'description': 'By QCT.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan.'}, {'type': 'SECONDARY', 'title': 'Reset of the Calcium Sensing Receptor?', 'timeFrame': '2 weeks after termination of medication.', 'description': 'Measured from effect on s-calcium and PTH weeks after termination of IMP', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Vertebral Fracture Assessment - Final Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Patients with vertebral fractures at one year reported.', 'description': 'Number of participants with vertebral fractures as assessed by VFA at final scan.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan.'}, {'type': 'SECONDARY', 'title': 'Change MDI-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '1.0'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-4.5', 'upperLimit': '1.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-3.0', 'upperLimit': '0.0'}]}]}], 'analyses': [{'pValue': '= 0.83', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 6 mths, one year.', 'description': 'Major Depression Inventory (MDI)-score, Baseline, 6 months, one year (week 52)., change between baseline and 1 year reported.\n\nThe Major Depression Inventory (MDI) is a mood questionnaire developed by the World Health Organization. To calculate the total score, a sum of ten individual items (each with an individual score between 0-5, with 0 indicating absence of a symptom and 5 indicating constant presence of a given symptom) is used. A higher score signifies deeper depression with 50 being the maximum score.', 'unitOfMeasure': 'MDI-score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final collection of MDI-questionnaires.'}, {'type': 'SECONDARY', 'title': 'Adverse Reactions.', 'timeFrame': 'Monthly up to one year.', 'description': 'All participants filled in questionnaires regarding symptoms related to the treatment.\n\nResults are reported in the Adverse Events section.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Bone Mineral Content', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'timeFrame': 'Baseline, one year', 'description': 'Measured at baseline and after one year at the lumbar spine and distal 1/3 of the non-dominant antebrachii.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected'}, {'type': 'SECONDARY', 'title': 'Change in Cortical Width.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '0.05', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, one year.', 'description': 'Measured at baseline and after one year at the distal non-dominant antebrachii.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the denosumab group experienced a wrist fracture prior to the final scan and was excluded. 4 patients did not provide data for the analysis due to errors in the technique of the obtained images.'}, {'type': 'SECONDARY', 'title': 'Change in Volumetric BMD for the Distal Forearm.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '3.7', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '4.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '= 0.0077', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, one year', 'description': 'Measured at baseline and after one year by QCT.', 'unitOfMeasure': 'mg/cm^3', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the denosumab group experienced a wrist fracture prior to the final scan and was excluded. 5 patients did not provide data for the analysis due to errors in the technique of the obtained images.'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Volumetric BMD for the Lumbar Spine.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.18', 'spread': '3.14', 'groupId': 'OG000'}, {'value': '5.66', 'spread': '1.85', 'groupId': 'OG001'}, {'value': '-2.94', 'spread': '1.96', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '= 0.011', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, one year', 'description': 'Measured at baseline and after one year by QCT.', 'unitOfMeasure': '% change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. Another scan could not be included due to a technical problems with the image analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Volumetric BMD for the Distal Forearm.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.53', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '-0.74', 'spread': '2.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '= 0.011', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, one year', 'description': 'Measured at baseline and after one year by QCT.', 'unitOfMeasure': '% change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final scan. One participant from the denosumab group experienced a wrist fracture prior to the final scan and was excluded. 5 patients did not provide data for the analysis due to errors in the technique of the obtained images.'}, {'type': 'SECONDARY', 'title': 'Mean p-PTH During Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}, {'units': 'p-PTH measurements', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '225', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '12.9'}, {'value': '13.4', 'groupId': 'OG001', 'lowerLimit': '12.7', 'upperLimit': '14.2'}, {'value': '9.9', 'groupId': 'OG002', 'lowerLimit': '9.5', 'upperLimit': '10.4'}]}]}], 'analyses': [{'pValue': '= 0.0001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Monthly up to one year.', 'description': 'Blood samples were acquired once every 4 weeks for safety-purposes.', 'unitOfMeasure': 'pmol/l', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'p-PTH measurements', 'denomUnitsSelected': 'p-PTH measurements'}, {'type': 'SECONDARY', 'title': 'Mean p-Phosphate During Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}, {'units': 'p-phosphate measurements', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '225', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.83', 'spread': '0.013', 'groupId': 'OG000'}, {'value': '0.76', 'spread': '0.012', 'groupId': 'OG001'}, {'value': '0.083', 'spread': '0.011', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.00001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Monthly up to one year.', 'description': 'Blood samples were acquired once every 4 weeks for safety-purposes.', 'unitOfMeasure': 'pmol/l', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'p-phosphate measurements', 'denomUnitsSelected': 'p-phosphate measurements'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in p-N-terminal Propeptide of Type I Procollagen (p-P1NP).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-63.1', 'groupId': 'OG000', 'lowerLimit': '-66.9', 'upperLimit': '-57.2'}, {'value': '-66.1', 'groupId': 'OG001', 'lowerLimit': '-75.9', 'upperLimit': '-55.4'}, {'value': '17.8', 'groupId': 'OG002', 'lowerLimit': '-11.0', 'upperLimit': '31.5'}]}]}], 'analyses': [{'pValue': '= 0.0001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Change from baseline at 48 weeks reported.', 'description': 'p-P1NP, change from baseline at 48 weeks.', 'unitOfMeasure': '% change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final blood-sampling.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in P-osteocalcin.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-60.0', 'groupId': 'OG000', 'lowerLimit': '-69.8', 'upperLimit': '-36.9'}, {'value': '-58.9', 'groupId': 'OG001', 'lowerLimit': '-66.9', 'upperLimit': '-49.0'}, {'value': '7.0', 'groupId': 'OG002', 'lowerLimit': '-0.9', 'upperLimit': '36.9'}]}]}], 'analyses': [{'pValue': '= 0.0001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Change from baseline at 48 weeks reported.', 'description': 'p-osteocalcin, change from baseline at 48 weeks.', 'unitOfMeasure': '% change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final blood-sampling.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in S-bone-specific Alkaline Phosphatase (BAP).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-40.0', 'groupId': 'OG000', 'lowerLimit': '-46.3', 'upperLimit': '-24.1'}, {'value': '-46.3', 'groupId': 'OG001', 'lowerLimit': '-51.5', 'upperLimit': '-38.4'}, {'value': '9.7', 'groupId': 'OG002', 'lowerLimit': '-7.9', 'upperLimit': '32.5'}]}]}], 'analyses': [{'pValue': '= 0.0001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Change from baseline at 48 weeks reported.', 'description': 'S-Bone specific alkaline phosphatase, change from baseline at 48 weeks.', 'unitOfMeasure': '% change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final blood-sampling.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in p-Tartrate-resistant Acid Phosphatase 5b (Trap5b).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-27.8', 'groupId': 'OG000', 'lowerLimit': '-34.1', 'upperLimit': '-2.3'}, {'value': '-36.7', 'groupId': 'OG001', 'lowerLimit': '-51.8', 'upperLimit': '-16.4'}, {'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '-4.9', 'upperLimit': '19.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Change from baseline at 48 weeks reported.', 'description': 'P-Trap5b, change 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From Baseline in P-fibroblast Growth Factor 23 (FGF23).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.8', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '52.9'}, {'value': '20.4', 'groupId': 'OG001', 'lowerLimit': '-13.6', 'upperLimit': '58.2'}, {'value': '28.0', 'groupId': 'OG002', 'lowerLimit': '-25.9', 'upperLimit': '64.7'}]}]}], 'analyses': [{'pValue': '= 0.85', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Change from baseline at 48 weeks reported.', 'description': 'P-FGF23 , change from baseline at 48 weeks.', 'unitOfMeasure': '% change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final blood-sampling.'}, {'type': 'SECONDARY', 'title': 'Changes in p-25-vitamin D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 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'unitOfMeasure': 'nmol/l', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final blood-sampling.'}, {'type': 'SECONDARY', 'title': 'Changes in s-1,25-vitamin D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '35.0'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '-15.0', 'upperLimit': '25.5'}, {'value': '26.0', 'groupId': 'OG002', 'lowerLimit': '14.0', 'upperLimit': '36.0'}]}]}], 'analyses': [{'pValue': '= 0.18', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Change from baseline at 48 weeks reported.', 'description': 'S-1,25-vitD, change from baseline at 48 weeks.', 'unitOfMeasure': 'pmol/l', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final blood-sampling.'}, {'type': 'SECONDARY', 'title': 'Patients With Nephrocalcinosis, Final Scan.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'OG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, one year', 'description': 'Number of subjects w. renal calcifications at final scan.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the combined treatment-group was not included in the analysis due to withdrawal before the final blood-sampling.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Safety Measures', 'timeFrame': 'Monthly up to one year.', 'description': 'Biochemical measures of changes in liver, infection, kidney and electrolyte-status and urinary excretion of calcium.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'FG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'FG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Combined Treatment.', 'description': '15 subjects were treated with combined 60mg denosumab every six months, 30 mg cinacalcet daily and 50 micrograms vitamin-D3 daily.'}, {'id': 'BG001', 'title': 'Denosumab Monotherapy', 'description': '16 subjects received 60 mg denosumab every six months, placebo and 50 micrograms vitamin-D daily.'}, {'id': 'BG002', 'title': 'Placebo', 'description': '15 subjects will receive a saline injection every six months(blinded), placebo-tablets and 50 micrograms vitamin-D daily.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '65.1', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '65.4', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '68.0', 'spread': '7.0', 'groupId': 'BG002'}, {'value': '66.15', 'spread': '9.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'T-score Lumbar Spine (LS) by Dual X-ray Absorptiometry (DXA)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '0.93', 'groupId': 'BG000'}, {'value': '-2.0', 'spread': '0.68', 'groupId': 'BG001'}, {'value': '-1.3', 'spread': '0.85', 'groupId': 'BG002'}, {'value': '-1.7', 'spread': '0.87', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline Bone mineral density (BMD) at lumbar spine (L2-L4) T-score. The T-score is the number of units that the bone density is above or below the average. -1 and above-bone density is considered normal; Between -1 and -2.5-is a sign of osteopenia, a condition in which bone density is below normal and may lead to osteoporosis. -2.5 and below-indicates osteoporosis', 'unitOfMeasure': 'T-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'T-score TH (by DXA)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '-1.4', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '-1.1', 'spread': '0.5', 'groupId': 'BG002'}, {'value': '-1.3', 'spread': '0.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline Bone mineral density (BMD) at Total Hip (TH) T-score. The T-score is the number of units that the bone density is above or below the average. -1 and above-bone density is considered normal; Between -1 and -2.5-is a sign of osteopenia, a condition in which bone density is below normal and may lead to osteoporosis. -2.5 and below-indicates osteoporosis.', 'unitOfMeasure': 'T-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'T-score FN (by DXA)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '-1.9', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '-1.7', 'spread': '0.6', 'groupId': 'BG002'}, {'value': '-1.88', 'spread': '0.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline Bone mineral density (BMD) at Femoral Neck (FN) T-score. The T-score is the number of units that the bone density is above or below the average. -1 and above-bone density is considered normal; Between -1 and -2.5-is a sign of osteopenia, a condition in which bone density is below normal and may lead to osteoporosis. -2.5 and below-indicates osteoporosis.', 'unitOfMeasure': 'T-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'T-score 1/3 FA (by DXA)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '-2.4', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '-2.8', 'spread': '0.9', 'groupId': 'BG002'}, {'value': '-2.5', 'spread': '1.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline Bone mineral density (BMD) at 1/3 distal forearm (1/3 FA)T-score. The T-score is the number of units that the bone density is above or below the average. -1 and above-bone density is considered normal; Between -1 and -2.5-is a sign of osteopenia, a condition in which bone density is below normal and may lead to osteoporosis. -2.5 and below-indicates osteoporosis.', 'unitOfMeasure': 'T-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Volumetric Bone Mineral Density (vBMD) LS', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '96.4', 'spread': '28.1', 'groupId': 'BG000'}, {'value': '99.7', 'spread': '24.0', 'groupId': 'BG001'}, {'value': '94.2', 'spread': '25.4', 'groupId': 'BG002'}, {'value': '96.9', 'spread': '25.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline lumbar spine BMD by quantitative computed tomography (QCT)', 'unitOfMeasure': 'mg/cm^3', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'vBMD distal forearm', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '183.5', 'spread': '32.0', 'groupId': 'BG000'}, {'value': '194.9', 'spread': '37.6', 'groupId': 'BG001'}, {'value': '181.4', 'spread': '35.5', 'groupId': 'BG002'}, {'value': '192.6', 'spread': '34.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Bone Mineral Density at the distal forearm by QCT', 'unitOfMeasure': 'mg/cm^3', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cortical width', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1.23', 'spread': '0.5', 'groupId': 'BG000'}, {'value': '1.19', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '1.14', 'spread': '0.4', 'groupId': 'BG002'}, {'value': '1.2', 'spread': '0.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline cortical Width of the distal forearm.', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Nephrolithiasis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Subjects with nephrolithiasis at baseline', 'unitOfMeasure': 'Participants'}, {'title': 'Nephrocalcinosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Subjects with nephrocalcinosis at baseline', 'unitOfMeasure': 'Participants'}, {'title': 'Pancreas calcifications', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Subjects with pancreatic calcifications at baseline', 'unitOfMeasure': 'Participants'}, {'title': 'Fracture by Vertebral Fracture Assessment (VFA)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Subjects with vertebral fractures by VFA at baseline', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '27.7', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '27.4', 'spread': '4.8', 'groupId': 'BG001'}, {'value': '28.4', 'spread': '3.9', 'groupId': 'BG002'}, {'value': '27.8', 'spread': '4.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index at baseline', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ionized Calcium', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1.39', 'spread': '0.08', 'groupId': 'BG000'}, {'value': '1.39', 'spread': '0.078', 'groupId': 'BG001'}, {'value': '1.39', 'spread': '0.08', 'groupId': 'BG002'}, {'value': '1.39', 'spread': '0.06', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline ionized calcium levels.', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'P-Parathyroid Hormone (PTH)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '12.1', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '13.1', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '11.2', 'spread': '4.3', 'groupId': 'BG002'}, {'value': '12.1', 'spread': '5.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline Parathyroid Hormone level.', 'unitOfMeasure': 'pmol/l', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Agatston Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'BG000', 'lowerLimit': '0.7', 'upperLimit': '25.9'}, {'value': '10.1', 'groupId': 'BG001', 'lowerLimit': '0.3', 'upperLimit': '470.3'}, {'value': '55.7', 'groupId': 'BG002', 'lowerLimit': '6.8', 'upperLimit': '144.6'}, {'value': '15.5', 'groupId': 'BG003', 'lowerLimit': '0.65', 'upperLimit': '129.6'}]}]}], 'paramType': 'MEDIAN', 'description': 'Agatston score is a score based on the extent of coronary artery calcification calculated on the amount of plaque observed in a CT scan. A score of zero indicates absence of coronary calcium, 1-10: minimal calcification, 11-100 mild calcification, 101-400 moderate calcification, \\>400 severe calcification.\n\nThus the score increases with increasing level of calcification in the coronary vessels.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'U-Calcium', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '338', 'groupId': 'BG000', 'lowerLimit': '159', 'upperLimit': '419'}, {'value': '276', 'groupId': 'BG001', 'lowerLimit': '218', 'upperLimit': '555'}, {'value': '314', 'groupId': 'BG002', 'lowerLimit': '222', 'upperLimit': '373'}, {'value': '284', 'groupId': 'BG003', 'lowerLimit': '218', 'upperLimit': '393'}]}]}], 'paramType': 'MEDIAN', 'description': 'Baseline urine calcium excretion per day.', 'unitOfMeasure': 'mg/d', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'U-Phosphorous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '28.5', 'groupId': 'BG000', 'lowerLimit': '25.7', 'upperLimit': '33.6'}, {'value': '32.2', 'groupId': 'BG001', 'lowerLimit': '26.5', 'upperLimit': '37.0'}, {'value': '35.2', 'groupId': 'BG002', 'lowerLimit': '23.6', 'upperLimit': '39.5'}, {'value': '32.0', 'groupId': 'BG003', 'lowerLimit': '25.6', 'upperLimit': '37.9'}]}]}], 'paramType': 'MEDIAN', 'description': 'Baseline daily excretion of phosphorous in urine.', 'unitOfMeasure': 'mmol/d', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'P-Phosphorous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0.77', 'spread': '0.15', 'groupId': 'BG000'}, {'value': '0.77', 'spread': '0.16', 'groupId': 'BG001'}, {'value': '0.79', 'spread': '0.12', 'groupId': 'BG002'}, {'value': '0.78', 'spread': '0.14', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline p-phosphorous.', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Major Depression Inventory score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '11'}, {'value': '5', 'groupId': 'BG001', 'lowerLimit': '1.5', 'upperLimit': '8.5'}, {'value': '5', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '7'}, {'value': '5', 'groupId': 'BG003', 'lowerLimit': '2', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'description': 'The Major Depression Inventory (MDI) is a mood questionnaire developed by the World Health Organization. To calculate the total score, a sum of ten individual items (each with an individual score between 0-5, with 0 indicating absence of a symptom and 5 indicating constant presence of a given symptom) is used. A higher score signifies deeper depression with 50 being the maximum score.', 'unitOfMeasure': 'MDI-points', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-10', 'size': 1100305, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-31T14:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-01', 'studyFirstSubmitDate': '2017-01-16', 'resultsFirstSubmitDate': '2020-07-24', 'studyFirstSubmitQcDate': '2017-01-20', 'lastUpdatePostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-01', 'studyFirstPostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety Measures', 'timeFrame': 'Monthly up to one year.', 'description': 'Biochemical measures of changes in liver, infection, kidney and electrolyte-status and urinary excretion of calcium.'}], 'primaryOutcomes': [{'measure': 'Change in Lumbar Spine Bone Mineral Density', 'timeFrame': 'Baseline,one year', 'description': 'Change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan.'}, {'measure': 'Change in Total Hip Bone Mineral Density', 'timeFrame': 'Baseline,one year', 'description': 'Change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan.'}, {'measure': 'Change in Femoral Neck Bone Mineral Density', 'timeFrame': 'Baseline,one year', 'description': 'Change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan.'}, {'measure': 'Change in 1/3 Forearm Bone Mineral Density', 'timeFrame': 'Baseline,one year', 'description': 'Change of Bone Mineral Density after one year of treatment from baseline. Measured with Dual-energy X-ray absorptiometry (DXA)-scan.'}, {'measure': 'Percentage Change in Lumbar Spine Bone Mineral Density', 'timeFrame': 'Baseline,one year', 'description': 'Percentage change of Bone Mineral Density after one year of treatment from baseline.\n\nMeasured with Dual-energy X-ray absorptiometry (DXA)-scan.'}, {'measure': 'Percentage Change in Total Hip Bone Mineral Density', 'timeFrame': 'Baseline,one year', 'description': 'Percentage change of Bone Mineral Density after one year of treatment from baseline.\n\nMeasured with Dual-energy X-ray absorptiometry (DXA)-scan.'}, {'measure': 'Percentage Change in Femoral Neck Bone Mineral Density', 'timeFrame': 'Baseline,one year', 'description': 'Percentage change of Bone Mineral Density after one year of treatment from baseline.\n\nMeasured with Dual-energy X-ray absorptiometry (DXA)-scan.'}, {'measure': 'Percentage Change in 1/3 Forearm Bone Mineral Density', 'timeFrame': 'Baseline,one year', 'description': 'Percentage change of Bone Mineral Density after one year of treatment from baseline.\n\nMeasured with Dual-energy X-ray absorptiometry (DXA)-scan.'}], 'secondaryOutcomes': [{'measure': 'Change in Volumetric BMD for the Lumbar Spine.', 'timeFrame': 'Baseline, one year', 'description': 'Measured at baseline and after one year by QCT.'}, {'measure': 'Mean P-calcium During Treatment.', 'timeFrame': 'Monthly up to one year.', 'description': 'Blood samples were acquired once every 4 weeks for safety-purposes.'}, {'measure': 'Percent Change From Baseline in P-carboxy-terminal Collagen Crosslinks (CTX)', 'timeFrame': 'Change from baseline at 48 weeks reported.', 'description': 'p-CTX, change from baseline at 48 weeks.'}, {'measure': 'Median Agatstons Score Final', 'timeFrame': 'Baseline, one year', 'description': 'Simultaneously with QCT-measurements coronary calcification was be assessed. Agatston score is a score based on the extent of coronary artery calcification calculated on the amount of plaque observed in a CT scan. A score of zero indicates absence of coronary calcium, 1-10: minimal calcification, 11-100 mild calcification, 101-400 moderate calcification, \\>400 severe calcification.\n\nThus the score increases with increasing level of calcification in the coronary vessels.'}, {'measure': 'Patients With Nephrolithiasis Final Scan.', 'timeFrame': 'Patients with nephrolithiasis at one year reported.', 'description': 'Number of subjects w. renal stones at final scan.'}, {'measure': 'Patients With Pancreas-calcifications Final Scan.', 'timeFrame': 'Patients with pancreas-calcifications at one year reported.', 'description': 'By QCT.'}, {'measure': 'Reset of the Calcium Sensing Receptor?', 'timeFrame': '2 weeks after termination of medication.', 'description': 'Measured from effect on s-calcium and PTH weeks after termination of IMP'}, {'measure': 'Vertebral Fracture Assessment - Final Scan', 'timeFrame': 'Patients with vertebral fractures at one year reported.', 'description': 'Number of participants with vertebral fractures as assessed by VFA at final scan.'}, {'measure': 'Change MDI-score', 'timeFrame': 'Baseline, 6 mths, one year.', 'description': 'Major Depression Inventory (MDI)-score, Baseline, 6 months, one year (week 52)., change between baseline and 1 year reported.\n\nThe Major Depression Inventory (MDI) is a mood questionnaire developed by the World Health Organization. To calculate the total score, a sum of ten individual items (each with an individual score between 0-5, with 0 indicating absence of a symptom and 5 indicating constant presence of a given symptom) is used. A higher score signifies deeper depression with 50 being the maximum score.'}, {'measure': 'Adverse Reactions.', 'timeFrame': 'Monthly up to one year.', 'description': 'All participants filled in questionnaires regarding symptoms related to the treatment.\n\nResults are reported in the Adverse Events section.'}, {'measure': 'Bone Mineral Content', 'timeFrame': 'Baseline, one year', 'description': 'Measured at baseline and after one year at the lumbar spine and distal 1/3 of the non-dominant antebrachii.'}, {'measure': 'Change in Cortical Width.', 'timeFrame': 'Baseline, one year.', 'description': 'Measured at baseline and after one year at the distal non-dominant antebrachii.'}, {'measure': 'Change in Volumetric BMD for the Distal Forearm.', 'timeFrame': 'Baseline, one year', 'description': 'Measured at baseline and after one year by QCT.'}, {'measure': 'Percentage Change in Volumetric BMD for the Lumbar Spine.', 'timeFrame': 'Baseline, one year', 'description': 'Measured at baseline and after one year by QCT.'}, {'measure': 'Percentage Change in Volumetric BMD for the Distal Forearm.', 'timeFrame': 'Baseline, one year', 'description': 'Measured at baseline and after one year by QCT.'}, {'measure': 'Mean p-PTH During Treatment.', 'timeFrame': 'Monthly up to one year.', 'description': 'Blood samples were acquired once every 4 weeks for safety-purposes.'}, {'measure': 'Mean p-Phosphate During Treatment.', 'timeFrame': 'Monthly up to one year.', 'description': 'Blood samples were acquired once every 4 weeks for safety-purposes.'}, {'measure': 'Percent Change From Baseline in p-N-terminal Propeptide of Type I Procollagen (p-P1NP).', 'timeFrame': 'Change from baseline at 48 weeks reported.', 'description': 'p-P1NP, change from baseline at 48 weeks.'}, {'measure': 'Percent Change From Baseline in P-osteocalcin.', 'timeFrame': 'Change from baseline at 48 weeks reported.', 'description': 'p-osteocalcin, change from baseline at 48 weeks.'}, {'measure': 'Percent Change From Baseline in S-bone-specific Alkaline Phosphatase (BAP).', 'timeFrame': 'Change from baseline at 48 weeks reported.', 'description': 'S-Bone specific alkaline phosphatase, change from baseline at 48 weeks.'}, {'measure': 'Percent Change From Baseline in p-Tartrate-resistant Acid Phosphatase 5b (Trap5b).', 'timeFrame': 'Change from baseline at 48 weeks reported.', 'description': 'P-Trap5b, change from baseline at 48 weeks.'}, {'measure': 'Percent Change From Baseline in p-Sclerostin.', 'timeFrame': 'Change from baseline at 48 weeks reported.', 'description': 'P-Sclerostin, change from baseline at 48 weeks.'}, {'measure': 'Percent Change From Baseline in P-fibroblast Growth Factor 23 (FGF23).', 'timeFrame': 'Change from baseline at 48 weeks reported.', 'description': 'P-FGF23 , change from baseline at 48 weeks.'}, {'measure': 'Changes in p-25-vitamin D', 'timeFrame': 'Change from baseline at 48 weeks reported.', 'description': 'P-25-vitD , change from baseline at 48 weeks.'}, {'measure': 'Changes in s-1,25-vitamin D', 'timeFrame': 'Change from baseline at 48 weeks reported.', 'description': 'S-1,25-vitD, change from baseline at 48 weeks.'}, {'measure': 'Patients With Nephrocalcinosis, Final Scan.', 'timeFrame': 'Baseline, one year', 'description': 'Number of subjects w. renal calcifications at final scan.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary Hyperparathyroidism', 'Parathyroid Adenoma', 'Parathyroid Hyperplasia', 'Cinacalcet', 'Denosumab', 'Drug Therapy', 'Bone Mineral Density', 'Calcium'], 'conditions': ['Primary Hyperparathyroidism', 'Parathyroid Adenoma', 'Parathyroid Hyperplasia']}, 'referencesModule': {'references': [{'pmid': '32333877', 'type': 'DERIVED', 'citation': 'Leere JS, Karmisholt J, Robaczyk M, Lykkeboe S, Handberg A, Steinkohl E, Brondum Frokjaer J, Vestergaard P. Denosumab and cinacalcet for primary hyperparathyroidism (DENOCINA): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2020 May;8(5):407-417. doi: 10.1016/S2213-8587(20)30063-2.'}]}, 'descriptionModule': {'briefSummary': 'The only known cure for primary hyperparathyroidism is surgical removal of one or more parathyroid glands. Some patients however, do not fulfill criteria for surgery or do not want to undergo a procedure due to fear of the associated risks. Therefore a medical alternative is warranted.\n\nThis study aims to evaluate the effects of Denosumab alone, and in combination with Cinacalcet, as a medical treatment for patients suffering from primary hyperparathyroidism, with mild osteoporosis. To the best of our knowledge no previously reported randomized controlled trial has investigated the use of denosumab in primary hyperparathyroidism.\n\n60 patients will be enrolled in three different treatment-groups: 20 receiving both Denosumab and Cinacalcet, 20 Denosumab and placebo and 20 placebo and placebo. Patients included do not meet the criteria for, or have no wish for a surgical procedure.\n\nBy combining the two drugs, this study could possibly contribute to the discovery of a realistic medical alternative to surgery. It is expected that the therapy will be able to both control s-calcium and s-intact parathyroid hormone (iPTH), and simultaneously enhance bone-structure. The therapy thus has the potential of preventing fractures and possibly other long-term effects of primary hyperparathyroidism such as formation of kidney stones, and coronary calcification. Another objective of this project is to investigate whether the combined therapy can facilitate an actual reset of the Calcium-sensing receptor, and thereby de facto cure the disease.', 'detailedDescription': 'Background/Context:\n\nThis project deals with medical treatment of primary hyperparathyroidism. The only cure currently available is surgical removal of one or more parathyroid glands, but this option is neither feasible, nor desirable in all patients with the diagnosis.\n\nToday a major group of patients are being diagnosed by coincidence with biochemical blood-screening, and are therefore in an asymptomatic state of the disease at the time of diagnosis. Long term studies show that these patients over time often have progression in their disease, and develop complications such as osteoporosis. Thus a medical alternative is warranted.\n\nPrevious studies have investigated the effects of well known antiresorptive drugs such as bisphosphonates, as well as estrogen-related compounds. These drugs have had effects on particularly bone mineral density (BMD) and biochemical bone-turnover markers, but have been able only transiently to lower blood-calcium levels. Combined with too many unwanted side-effects and a high prevalence of contraindications for a large proportion of the patients needing treatment, these drugs have not provided a realistic alternative to surgery.\n\nTreatment today generally follows the international consensus for treatment of asymptomatic patients with primary hyperparathyroidism. Briefly this includes watchful waiting with biannual control-sessions for indication of surgery, screening for kidney stones/nephrolithiasis, osteoporosis and s-calcium - and s-iPTH levels.\n\nThis randomized controlled trial involves the drugs Cinacalcet og Denosumab. Denosumab has previously been shown to greatly improve BMD, lower s-calcium, lower the rate of bone-turnover and prevent osteoporotic fractures in several populations with different diseases, but has never been tested in a published randomized controlled trial in patients with primary hyperparathyroidism.\n\nCinacalcet has been proved able to lower s-iPTH, lower s-Calcium and thereby relieve symptoms of hypercalcaemia caused by primary hyperparathyroidism. It does not however, lower the rate of bone turnover, and it has not been show to improve BMD.\n\nBy combining the two drugs, this study could possibly contribute to the discovery of a realistic medical alternative to surgery. It is expected that the therapy will be able to both control s-calcium and s-iPTH, and simultaneously enhance bone-structure. The therapy thus has the potential of preventing fractures and possibly other long-term effects of primary hyperparathyroidism such as formation of kidney stones, and coronary calcification. Another objective of this project is to investigate whether the combined therapy can facilitate an actual reset of the Calcium-sensing receptor, and thereby de facto cure the disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women of 18 years of age or older.\n* T-score by Dual X-ray Absorptiometry (DXA) between -1,0 og -3,5\n* Patients from The North Jutland Region diagnosed with primary hyperparathyroidism at the Department of Endocrinology, Aalborg University Hospital. (Hypercalcaemia measured at two different time-points and simultaneous elevated/inappropriately high PTH, and exclusion of differential diagnosis.)\n\nExclusion Criteria:\n\n* Medical history of diseases leading to hypercalcaemia other than Primary Hyperparathyroidism.\n* Patients being treated with Denosumab or Cinacalcet prior to inclusion or previously treated with Denosumab or Cinacalcet.\n* Moderately - Severely decreased liver function (alanine aminotransferase \\>250u/l, gamma-glutamyl transferase\\>150u/l, Bilirubin \\>30)\n* Acute myocardial infarction or apoplexia in the 3 months before inclusion.\n* Medical record of heart failure\n* Risk factors of prolonged corrected QT interval (QTc).\n* Open lesions from oral surgery.\n* Primary diseases of the bone other than osteoporosis.\n* Patients suffering from kidney disease or renal failure.\n* Patients under treatment with thiazide or lithium.\n* Medical record of generalized seizures or epilepsy.\n* Active malignant disease.\n* Known allergies towards the specified medicinal products (IMPs).\n* Pregnancy or breastfeeding.\n* Fertile women who do not agree to the usage of effective contraception.\n* Other circumstances, evaluated by the responsible investigator, making the subject unsuitable for participation.'}, 'identificationModule': {'nctId': 'NCT03027557', 'acronym': 'DENOCINA', 'briefTitle': 'Treatment of Primary Hyperparathyroidism With Denosumab and Cinacalcet.', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Treatment of Primary Hyperparathyroidism With Denosumab and Cinacalcet.', 'orgStudyIdInfo': {'id': '180987'}, 'secondaryIdInfos': [{'id': '2016-001510-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combined treatment.', 'description': '20 subjects will be treated with combined 60mg denosumab bi-annually , 30 mg cinacalcet daily and 50 micrograms vitamin-D daily.', 'interventionNames': ['Drug: Cinacalcet 30 mg Tablet', 'Drug: Denosumab Inj 60 mg/ml']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Monotherapy', 'description': '20 subjects will receive 60mg denosumab bi-annually, placebo and 50 micrograms vitamin-D daily.', 'interventionNames': ['Drug: Denosumab Inj 60 mg/ml', 'Other: Placebo tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '20 subjects will receive a saline injection bi-annually (blinded), placebo-tablets and 50 micrograms vitamin-D daily.', 'interventionNames': ['Other: Placebo tablets', 'Other: Saline Injection (Placebo)']}], 'interventions': [{'name': 'Cinacalcet 30 mg Tablet', 'type': 'DRUG', 'otherNames': ['Mimpara', 'Sensipar'], 'description': 'Participants in one arm will receive 30 mg cinacalcet each day.', 'armGroupLabels': ['Combined treatment.']}, {'name': 'Denosumab Inj 60 mg/ml', 'type': 'DRUG', 'otherNames': ['Prolia', 'Xgeva'], 'description': 'Participants in two arms will receive 60 mg Denosumab biannually.', 'armGroupLabels': ['Combined treatment.', 'Monotherapy']}, {'name': 'Placebo tablets', 'type': 'OTHER', 'description': 'Participants in two arms will receive one placebo-tablet each day.', 'armGroupLabels': ['Monotherapy', 'Placebo']}, {'name': 'Saline Injection (Placebo)', 'type': 'OTHER', 'otherNames': ['Sodium Chloride (NaCl) Fresenius "Kabi"'], 'description': 'Participants in one arm will receive saline injections as placebo for denosumab.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Julius Simoni Leere, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg University and Aalborg University Hospital'}, {'name': 'Peter Vestergaard, DMSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aalborg University and Aalborg University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peter Vestergaard', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aalborg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, DMSc, Consultant', 'investigatorFullName': 'Peter Vestergaard', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}