Viewing Study NCT00091793

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Ignite Creation Date: 2025-12-25 @ 12:59 AM
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Study NCT ID: NCT00091793
Status: COMPLETED
Last Update Posted: 2010-12-31
First Post: 2004-09-17
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069448', 'term': 'Denosumab'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'otherNumAtRisk': 165, 'otherNumAffected': 157, 'seriousNumAtRisk': 165, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Denosumab 60 mg Q6M', 'otherNumAtRisk': 164, 'otherNumAffected': 156, 'seriousNumAtRisk': 164, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 7}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 41}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 33}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Shoulder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 9.0'}], 'seriousEvents': [{'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Incisional hernia, obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Breast cancer in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Mycosis fungoides', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Facial palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pelvic prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Uterine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'MedDRA 9.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg Q6M'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '7.2'}, {'value': '-.6', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '.1'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '7', 'ciLowerLimit': '6.2', 'ciUpperLimit': '7.8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 Months', 'description': 'Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.', 'unitOfMeasure': 'Percent Change from Baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized subjects who have a non-missing baseline and at least 1 non-missing postbaseline evaluation at or prior to month 24. LOCF was used as imputation method.'}, {'type': 'SECONDARY', 'title': 'Total Hip Bone Mineral Density Percent Change From Baseline at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg Q6M'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '3.7'}, {'value': '-1.1', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '-.8'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 Months', 'description': 'Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.', 'unitOfMeasure': 'Percent Change from Baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg Q6M'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '3.3'}, {'value': '-.9', 'groupId': 'OG001', 'lowerLimit': '-1.4', 'upperLimit': '-.3'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 Months', 'description': 'Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.', 'unitOfMeasure': 'Percent Change from Baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Trochanter Bone Mineral Density Percent Change From Baseline at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg Q6M'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '5.6'}, {'value': '-.8', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '-.3'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 months', 'description': 'Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.', 'unitOfMeasure': 'Percent Change from Baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg Q6M'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '.9', 'upperLimit': '1.9'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-2.6', 'upperLimit': '-1.6'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 months', 'description': 'Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.', 'unitOfMeasure': 'Percent Change from Baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg Q6M'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '2.9'}, {'value': '-1.4', 'groupId': 'OG001', 'lowerLimit': '-1.9', 'upperLimit': '-.8'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 months', 'description': 'Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.', 'unitOfMeasure': 'Percent Change from Baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg Q6M'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '14.4'}, {'value': '-.7', 'groupId': 'OG001', 'lowerLimit': '-6.6', 'upperLimit': '5.3'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 months', 'description': 'Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).', 'unitOfMeasure': 'Percent Change from Baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg Q6M'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '.3', 'groupId': 'OG000', 'lowerLimit': '-.1', 'upperLimit': '.8'}, {'value': '-1.4', 'groupId': 'OG001', 'lowerLimit': '-1.8', 'upperLimit': '-.9'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 months', 'description': 'Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).', 'unitOfMeasure': 'Percent Change from Baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Denosumab 60 mg Q6M'}, {'id': 'OG001', 'title': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '.8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1.6'}, {'value': '-1.9', 'groupId': 'OG001', 'lowerLimit': '-2.6', 'upperLimit': '-1.1'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 months', 'description': 'Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).', 'unitOfMeasure': 'Percent Change from Baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Denosumab 60 mg Q6M'}, {'id': 'FG001', 'title': 'Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': 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'dispFirstSubmitQcDate': '2009-11-23', 'resultsFirstSubmitDate': '2009-12-22', 'studyFirstSubmitQcDate': '2004-09-20', 'dispFirstPostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2010-12-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-12-22', 'studyFirstPostDateStruct': {'date': '2004-09-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24', 'timeFrame': '24 Months', 'description': 'Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.'}], 'secondaryOutcomes': [{'measure': 'Total Hip Bone Mineral Density Percent Change From Baseline at Month 24', 'timeFrame': '24 Months', 'description': 'Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.'}, {'measure': 'Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24', 'timeFrame': '24 Months', 'description': 'Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.'}, {'measure': 'Trochanter Bone Mineral Density Percent Change From Baseline at Month 24', 'timeFrame': '24 months', 'description': 'Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.'}, {'measure': 'Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24', 'timeFrame': '24 months', 'description': 'Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.'}, {'measure': 'Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24', 'timeFrame': '24 months', 'description': 'Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.'}, {'measure': 'Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24', 'timeFrame': '24 months', 'description': 'Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).'}, {'measure': 'Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24', 'timeFrame': '24 months', 'description': 'Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).'}, {'measure': 'Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24', 'timeFrame': '24 months', 'description': 'Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).'}]}, 'conditionsModule': {'keywords': ['Osteoporosis', 'Postmenopausal'], 'conditions': ['Postmenopausal Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '18381571', 'type': 'RESULT', 'citation': 'Bone HG, Bolognese MA, Yuen CK, Kendler DL, Wang H, Liu Y, San Martin J. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab. 2008 Jun;93(6):2149-57. doi: 10.1210/jc.2007-2814. Epub 2008 Apr 1.'}, {'pmid': '19345291', 'type': 'RESULT', 'citation': 'Engelke K, Libanati C, Liu Y, Wang H, Austin M, Fuerst T, Stampa B, Timm W, Genant HK. Quantitative computed tomography (QCT) of the forearm using general purpose spiral whole-body CT scanners: accuracy, precision and comparison with dual-energy X-ray absorptiometry (DXA). Bone. 2009 Jul;45(1):110-8. doi: 10.1016/j.bone.2009.03.669. Epub 2009 Apr 2.'}, {'pmid': '21289258', 'type': 'DERIVED', 'citation': 'Bone HG, Bolognese MA, Yuen CK, Kendler DL, Miller PD, Yang YC, Grazette L, San Martin J, Gallagher JC. Effects of denosumab treatment and discontinuation on bone mineral density and bone turnover markers in postmenopausal women with low bone mass. J Clin Endocrinol Metab. 2011 Apr;96(4):972-80. doi: 10.1210/jc.2010-1502. Epub 2011 Feb 2.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}, {'url': 'http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf', 'label': 'Notice regarding posted summaries of trial results'}]}, 'descriptionModule': {'briefSummary': 'This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this population.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Eligibility Criteria\n\n\\- Postmenopausal women with Osteopenia (lumbar spine bone mineral density T-score between 1.0 and -2.5)'}, 'identificationModule': {'nctId': 'NCT00091793', 'briefTitle': 'Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Randomized, Double-Blind Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis', 'orgStudyIdInfo': {'id': '20040132'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMG 162', 'description': '60 mg/mL denosumab given day 1, month 6, month 12 and month 18', 'interventionNames': ['Drug: AMG 162']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo given day 1, month 6, month 12 and month 18', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AMG 162', 'type': 'DRUG', 'description': '60 mg/mL denosumab given day 1, month 6, month 12 and month 18', 'armGroupLabels': ['AMG 162']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo given at day 1, month 6, month 12 and month 18', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Global Development Leader', 'oldOrganization': 'Amgen Inc.'}}}}