Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-02-01 @ 2:17 PM
Study NCT ID:
NCT01992159
Status:
COMPLETED
Last Update Posted:
2019-03-25
First Post:
2013-11-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C557282', 'term': 'romosozumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@amgen.com', '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 multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '15 months', 'description': 'Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.', 'otherNumAtRisk': 63, 'otherNumAffected': 20, 'seriousNumAtRisk': 63, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Romosozumab 70 mg', 'description': 'Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.', 'otherNumAtRisk': 63, 'otherNumAffected': 33, 'seriousNumAtRisk': 63, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Romosozumab 140 mg', 'description': 'Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.', 'otherNumAtRisk': 63, 'otherNumAffected': 29, 'seriousNumAtRisk': 63, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Romosozumab 210 mg', 'description': 'Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.', 'otherNumAtRisk': 63, 'otherNumAffected': 32, 'seriousNumAtRisk': 63, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Heat illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': "Parkinson's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Endometrial hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG001', 'title': 'Romosozumab 70 mg', 'description': 'Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG002', 'title': 'Romosozumab 140 mg', 'description': 'Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG003', 'title': 'Romosozumab 210 mg', 'description': 'Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '1.8'}, {'value': '8.4', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '9.3'}, {'value': '13.3', 'groupId': 'OG002', 'lowerLimit': '12.1', 'upperLimit': '14.5'}, {'value': '16.9', 'groupId': 'OG003', 'lowerLimit': '15.5', 'upperLimit': '18.4'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '7.5', 'ciLowerLimit': '6.5', 'pValueComment': "P-values were adjusted for multiplicity using a combination of a sequential test procedure and Hochberg's method to control type 1 error for the primary endpoint.", 'groupDescription': 'The primary analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.', 'statisticalMethod': 'Repeated Measures Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '12.4', 'ciLowerLimit': '11.1', 'pValueComment': "P-values were adjusted for multiplicity using a combination of a sequential test procedure and Hochberg's method to control type 1 error for the primary endpoint.", 'groupDescription': 'The primary analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.', 'statisticalMethod': 'Repeated Measures Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Treatment Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '16.0', 'ciLowerLimit': '14.6', 'pValueComment': "One-sided p-values were adjusted for multiplicity using a combination of a sequential test procedure and Hochberg's method to control type 1 error for the primary endpoint.", 'groupDescription': 'The primary analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.', 'statisticalMethod': 'Repeated Measures Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, and had at least 1 postbaseline measurement (primary efficacy subset).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline at 6 Months in Bone Mineral Density at the Lumbar Spine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG001', 'title': 'Romosozumab 70 mg', 'description': 'Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG002', 'title': 'Romosozumab 140 mg', 'description': 'Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG003', 'title': 'Romosozumab 210 mg', 'description': 'Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.9'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '7.2'}, {'value': '10.2', 'groupId': 'OG002', 'lowerLimit': '9.2', 'upperLimit': '11.2'}, {'value': '13.1', 'groupId': 'OG003', 'lowerLimit': '11.7', 'upperLimit': '14.5'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '5.3', 'ciLowerLimit': '4.4', 'groupDescription': 'The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.', 'statisticalMethod': 'Repeated Measures Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '9.0', 'ciLowerLimit': '8.0', 'groupDescription': 'The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.', 'statisticalMethod': 'Repeated Measures Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Treatment Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '11.9', 'ciLowerLimit': '10.6', 'groupDescription': 'The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the lumbar spine as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.', 'statisticalMethod': 'Repeated Measures Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, and had at least 1 postbaseline measurement.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline at 6 Months in Bone Mineral Density at the Total Hip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG001', 'title': 'Romosozumab 70 mg', 'description': 'Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG002', 'title': 'Romosozumab 140 mg', 'description': 'Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG003', 'title': 'Romosozumab 210 mg', 'description': 'Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '-0.0', 'upperLimit': '1.3'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '2.0'}, {'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': '2.9'}, {'value': '3.2', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '3.9'}]}]}], 'analyses': [{'pValue': '0.1250', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-0.3', 'groupDescription': 'The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.', 'statisticalMethod': 'Repeated Measures Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '0.9', 'groupDescription': 'The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.', 'statisticalMethod': 'Repeated Measures Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Treatment Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '1.7', 'groupDescription': 'The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.', 'statisticalMethod': 'Repeated Measures Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, and had at least 1 postbaseline measurement.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to 12 Months in Bone Mineral Density at the Total Hip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG001', 'title': 'Romosozumab 70 mg', 'description': 'Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG002', 'title': 'Romosozumab 140 mg', 'description': 'Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG003', 'title': 'Romosozumab 210 mg', 'description': 'Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '-0.0', 'upperLimit': '1.3'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '2.8'}, {'value': '3.2', 'groupId': 'OG002', 'lowerLimit': '2.6', 'upperLimit': '3.9'}, {'value': '4.7', 'groupId': 'OG003', 'lowerLimit': '4.0', 'upperLimit': '5.5'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '0.7', 'groupDescription': 'The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.', 'statisticalMethod': 'Repeated Measures Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '1.8', 'groupDescription': 'The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.', 'statisticalMethod': 'Repeated Measures Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Treatment Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '4.1', 'ciLowerLimit': '3.3', 'groupDescription': 'The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the total hip as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.', 'statisticalMethod': 'Repeated Measures Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'Bone density was measured using dual-energy X-ray absorptiometry (DXA). 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DXA scans were analyzed by a central imaging reader.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, and had at least 1 postbaseline measurement.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to 12 Months in Bone Mineral Density at the Femoral Neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG001', 'title': 'Romosozumab 70 mg', 'description': 'Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG002', 'title': 'Romosozumab 140 mg', 'description': 'Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG003', 'title': 'Romosozumab 210 mg', 'description': 'Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '1.2'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '2.7'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '2.1', 'upperLimit': '3.8'}, {'value': '3.8', 'groupId': 'OG003', 'lowerLimit': '2.7', 'upperLimit': '4.9'}]}]}], 'analyses': [{'pValue': '0.0067', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '0.5', 'groupDescription': 'The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.', 'statisticalMethod': 'Repeated Measures Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '1.6', 'groupDescription': 'The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.', 'statisticalMethod': 'Repeated Measures Model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Treatment Difference', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '3.5', 'ciLowerLimit': '2.3', 'groupDescription': 'The analysis was based on a repeated measures model with the percent change from baseline at months 6 and 12 in BMD of the femoral neck as the dependent variable, and baseline BMD, machine type, interaction of baseline BMD and machine type, visit (categorical), treatment (categorical), and interaction of treatment and visit as the independent variables; using an unstructured variance covariance structure.', 'statisticalMethod': 'Repeated Measures Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 12 months', 'description': 'Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, and had at least 1 postbaseline measurement.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG001', 'title': 'Romosozumab 70 mg', 'description': 'Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG002', 'title': 'Romosozumab 140 mg', 'description': 'Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG003', 'title': 'Romosozumab 210 mg', 'description': 'Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '43.4', 'spread': '24.0', 'groupId': 'OG001'}, {'value': '65.9', 'spread': '25.7', 'groupId': 'OG002'}, {'value': '81.5', 'spread': '34.6', 'groupId': 'OG003'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.7', 'spread': '22.1', 'groupId': 'OG000'}, {'value': '32.2', 'spread': '22.9', 'groupId': 'OG001'}, {'value': '79.8', 'spread': '41.7', 'groupId': 'OG002'}, {'value': '101.6', 'spread': '41.1', 'groupId': 'OG003'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-10.9', 'spread': '18.5', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '18.4', 'groupId': 'OG001'}, {'value': '34.6', 'spread': '38.2', 'groupId': 'OG002'}, {'value': '59.8', 'spread': '40.5', 'groupId': 'OG003'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-11.5', 'spread': '20.3', 'groupId': 'OG000'}, {'value': '-13.1', 'spread': '18.3', 'groupId': 'OG001'}, {'value': '14.9', 'spread': '32.2', 'groupId': 'OG002'}, {'value': '25.5', 'spread': '33.4', 'groupId': 'OG003'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-8.9', 'spread': '23.3', 'groupId': 'OG000'}, {'value': '-16.8', 'spread': '26.0', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '28.0', 'groupId': 'OG002'}, {'value': '2.4', 'spread': '24.8', 'groupId': 'OG003'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '32.0', 'groupId': 'OG000'}, {'value': '-16.9', 'spread': '31.3', 'groupId': 'OG001'}, {'value': '-9.1', 'spread': '30.9', 'groupId': 'OG002'}, {'value': '-4.0', 'spread': '31.5', 'groupId': 'OG003'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '37.9', 'groupId': 'OG000'}, {'value': '-11.1', 'spread': '29.8', 'groupId': 'OG001'}, {'value': '-16.2', 'spread': '27.4', 'groupId': 'OG002'}, {'value': '-13.1', 'spread': '28.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 1, and months 1, 2, 3, 6, 9, and 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, had at least 1 postbaseline measurement and with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG001', 'title': 'Romosozumab 70 mg', 'description': 'Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG002', 'title': 'Romosozumab 140 mg', 'description': 'Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG003', 'title': 'Romosozumab 210 mg', 'description': 'Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.9', 'spread': '27.8', 'groupId': 'OG000'}, {'value': '-28.0', 'spread': '25.8', 'groupId': 'OG001'}, {'value': '-32.1', 'spread': '32.8', 'groupId': 'OG002'}, {'value': '-42.0', 'spread': '25.4', 'groupId': 'OG003'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.9', 'spread': '40.2', 'groupId': 'OG000'}, {'value': '-18.0', 'spread': '34.3', 'groupId': 'OG001'}, {'value': '-8.0', 'spread': '53.9', 'groupId': 'OG002'}, {'value': '-24.6', 'spread': '30.5', 'groupId': 'OG003'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.1', 'spread': '41.6', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '48.4', 'groupId': 'OG001'}, {'value': '14.9', 'spread': '67.8', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '49.1', 'groupId': 'OG003'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.1', 'spread': '49.0', 'groupId': 'OG000'}, {'value': '-5.5', 'spread': '48.3', 'groupId': 'OG001'}, {'value': '28.9', 'spread': '84.1', 'groupId': 'OG002'}, {'value': '8.1', 'spread': '53.8', 'groupId': 'OG003'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.6', 'spread': '49.8', 'groupId': 'OG000'}, {'value': '-10.8', 'spread': '52.2', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '71.8', 'groupId': 'OG002'}, {'value': '-13.4', 'spread': '40.6', 'groupId': 'OG003'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.6', 'spread': '56.6', 'groupId': 'OG000'}, {'value': '-13.2', 'spread': '53.0', 'groupId': 'OG001'}, {'value': '-8.0', 'spread': '55.7', 'groupId': 'OG002'}, {'value': '-15.3', 'spread': '44.8', 'groupId': 'OG003'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '35.4', 'spread': '81.7', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '47.2', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '73.5', 'groupId': 'OG002'}, {'value': '-10.5', 'spread': '53.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 1, and months 1, 2, 3, 6, 9, and 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, had at least 1 postbaseline measurement, and with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Osteocalcin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG001', 'title': 'Romosozumab 70 mg', 'description': 'Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG002', 'title': 'Romosozumab 140 mg', 'description': 'Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG003', 'title': 'Romosozumab 210 mg', 'description': 'Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '18.1', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '12.6', 'groupId': 'OG001'}, {'value': '7.9', 'spread': '17.0', 'groupId': 'OG002'}, {'value': '5.5', 'spread': '14.5', 'groupId': 'OG003'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '26.5', 'spread': '20.4', 'groupId': 'OG001'}, {'value': '51.2', 'spread': '31.9', 'groupId': 'OG002'}, {'value': '66.4', 'spread': '31.3', 'groupId': 'OG003'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.0', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '13.7', 'spread': '15.1', 'groupId': 'OG001'}, {'value': '39.3', 'spread': '31.6', 'groupId': 'OG002'}, {'value': '48.9', 'spread': '31.6', 'groupId': 'OG003'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.2', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '17.5', 'groupId': 'OG001'}, {'value': '28.4', 'spread': '29.7', 'groupId': 'OG002'}, {'value': '27.5', 'spread': '22.3', 'groupId': 'OG003'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-10.3', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '-5.5', 'spread': '18.8', 'groupId': 'OG001'}, {'value': '10.6', 'spread': '24.7', 'groupId': 'OG002'}, {'value': '9.3', 'spread': '19.2', 'groupId': 'OG003'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-8.4', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '-6.8', 'spread': '22.5', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '24.0', 'groupId': 'OG002'}, {'value': '-1.3', 'spread': '18.9', 'groupId': 'OG003'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.8', 'spread': '20.6', 'groupId': 'OG000'}, {'value': '-8.6', 'spread': '21.8', 'groupId': 'OG001'}, {'value': '-9.4', 'spread': '22.1', 'groupId': 'OG002'}, {'value': '-8.9', 'spread': '17.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 1, and months 1, 2, 3, 6, 9, and 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, had at least 1 postbaseline measurement, and with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG001', 'title': 'Romosozumab 70 mg', 'description': 'Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG002', 'title': 'Romosozumab 140 mg', 'description': 'Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG003', 'title': 'Romosozumab 210 mg', 'description': 'Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '14.0', 'spread': '14.5', 'groupId': 'OG001'}, {'value': '17.0', 'spread': '16.4', 'groupId': 'OG002'}, {'value': '20.1', 'spread': '17.9', 'groupId': 'OG003'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '22.1', 'groupId': 'OG000'}, {'value': '23.0', 'spread': '19.9', 'groupId': 'OG001'}, {'value': '51.3', 'spread': '27.6', 'groupId': 'OG002'}, {'value': '66.2', 'spread': '31.9', 'groupId': 'OG003'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.8', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '20.8', 'groupId': 'OG001'}, {'value': '31.8', 'spread': '27.9', 'groupId': 'OG002'}, {'value': '55.1', 'spread': '31.0', 'groupId': 'OG003'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-9.5', 'spread': '16.3', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '14.9', 'groupId': 'OG001'}, {'value': '23.5', 'spread': '26.5', 'groupId': 'OG002'}, {'value': '39.6', 'spread': '33.2', 'groupId': 'OG003'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.6', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '-9.0', 'spread': '19.0', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '21.6', 'groupId': 'OG002'}, {'value': '13.2', 'spread': '26.8', 'groupId': 'OG003'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.0', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '-10.7', 'spread': '21.7', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '25.3', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '23.8', 'groupId': 'OG003'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.3', 'spread': '22.7', 'groupId': 'OG000'}, {'value': '-13.2', 'spread': '19.9', 'groupId': 'OG001'}, {'value': '-13.7', 'spread': '23.3', 'groupId': 'OG002'}, {'value': '-9.3', 'spread': '21.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 1, and months 1, 2, 3, 6, 9, and 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, had at least 1 postbaseline measurement, and with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve Through Month 12 of P1NP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG001', 'title': 'Romosozumab 70 mg', 'description': 'Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG002', 'title': 'Romosozumab 140 mg', 'description': 'Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'OG003', 'title': 'Romosozumab 210 mg', 'description': 'Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '554.5', 'groupId': 'OG000', 'lowerLimit': '523.0', 'upperLimit': '585.9'}, {'value': '539.2', 'groupId': 'OG001', 'lowerLimit': '506.4', 'upperLimit': '572.0'}, {'value': '638.5', 'groupId': 'OG002', 'lowerLimit': '607.9', 'upperLimit': '669.2'}, {'value': '708.3', 'groupId': 'OG003', 'lowerLimit': '676.6', 'upperLimit': '740.0'}]}]}], 'analyses': [{'pValue': '0.5084', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.3', 'ciLowerLimit': '-60.8', 'ciUpperLimit': '30.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with the AUC of P1NP at month 12 as the dependent variable, and baseline P1NP and treatment (categorical) as the independent variables.'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '84.1', 'ciLowerLimit': '40.1', 'ciUpperLimit': '128.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with the AUC of P1NP at month 12 as the dependent variable, and baseline P1NP and treatment (categorical) as the independent variables.'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '153.8', 'ciLowerLimit': '109.2', 'ciUpperLimit': '198.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model with the AUC of P1NP at months 12 as the dependent variable, and baseline P1NP and treatment (categorical) as the independent variables.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, week 1 and months 1, 2, 3, 6, 9, and 12.', 'unitOfMeasure': 'ug*month/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who received at least 10 doses of the assigned randomized treatment, had never received any dose of incorrect treatment, and had no missing P1NP measurements.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'FG001', 'title': 'Romosozumab 70 mg', 'description': 'Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'FG002', 'title': 'Romosozumab 140 mg', 'description': 'Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'FG003', 'title': 'Romosozumab 210 mg', 'description': 'Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '63'}, {'groupId': 'FG003', 'numSubjects': '63'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '63'}, {'groupId': 'FG003', 'numSubjects': '63'}]}, {'type': 'Completed First 12 Months of Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '63'}, {'groupId': 'FG003', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '62'}, {'groupId': 'FG003', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at 24 centers in Japan. The first participant was enrolled on 12 October 2012 and the last participant enrolled on 15 October 2013.', 'preAssignmentDetails': 'Participants were randomized in a 1:1:1:1 ratio to receive placebo or romosozumab 70, 140, or 210 mg subcutaneous (SC) injection every month (QM) for 12 months. Upon completion of the 12-month treatment period, participants were followed for another 3 months for assessment of antiromosozumab antibody formation (follow-up period).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '252', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'BG001', 'title': 'Romosozumab 70 mg', 'description': 'Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'BG002', 'title': 'Romosozumab 140 mg', 'description': 'Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'BG003', 'title': 'Romosozumab 210 mg', 'description': 'Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '252', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '67.8', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '66.5', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '68.4', 'spread': '6.0', 'groupId': 'BG002'}, {'value': '68.3', 'spread': '5.9', 'groupId': 'BG003'}, {'value': '67.7', 'spread': '6.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '252', 'groupId': 'BG004'}]}], 'categories': [{'title': '< 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '93', 'groupId': 'BG004'}]}, {'title': '≥ 65 to < 75 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '112', 'groupId': 'BG004'}]}, {'title': '≥ 75 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '252', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '252', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '252', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Asian', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '252', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lumbar Spine Bone Mineral Density (BMD) T-score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '252', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '-2.69', 'spread': '0.52', 'groupId': 'BG000'}, {'value': '-2.73', 'spread': '0.57', 'groupId': 'BG001'}, {'value': '-2.65', 'spread': '0.66', 'groupId': 'BG002'}, {'value': '-2.72', 'spread': '0.42', 'groupId': 'BG003'}, {'value': '-2.70', 'spread': '0.54', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The T-score is the bone mineral density (BMD) at the site when compared to that of a healthy thirty-year-old. 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'STANDARD_DEVIATION'}, {'title': 'Femoral Neck BMD T-score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '252', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '-2.31', 'spread': '0.47', 'groupId': 'BG000'}, {'value': '-2.27', 'spread': '0.53', 'groupId': 'BG001'}, {'value': '-2.28', 'spread': '0.65', 'groupId': 'BG002'}, {'value': '-2.32', 'spread': '0.59', 'groupId': 'BG003'}, {'value': '-2.29', 'spread': '0.56', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'T-score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Serum Procollagen Type 1 N-telopeptide (P1NP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '251', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '52.4', 'groupId': 'BG000', 'lowerLimit': '41.9', 'upperLimit': '62.9'}, {'value': '51.9', 'groupId': 'BG001', 'lowerLimit': '40.5', 'upperLimit': '59.8'}, {'value': '47.6', 'groupId': 'BG002', 'lowerLimit': '37.7', 'upperLimit': '54.9'}, {'value': '50.9', 'groupId': 'BG003', 'lowerLimit': '38.0', 'upperLimit': '59.1'}, {'value': '50.5', 'groupId': 'BG004', 'lowerLimit': '38.6', 'upperLimit': '59.4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'μg/L', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Participants with available data'}, {'title': 'Serum Type 1 Collagen C-telopeptide (CTX)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '252', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '441.0', 'groupId': 'BG000', 'lowerLimit': '294.0', 'upperLimit': '692.0'}, {'value': '441.0', 'groupId': 'BG001', 'lowerLimit': '289.0', 'upperLimit': '678.0'}, {'value': '374.0', 'groupId': 'BG002', 'lowerLimit': '265.0', 'upperLimit': '552.0'}, {'value': '420.0', 'groupId': 'BG003', 'lowerLimit': '297.0', 'upperLimit': '690.0'}, {'value': '412.0', 'groupId': 'BG004', 'lowerLimit': '288.5', 'upperLimit': '628.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Osteocalcin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '252', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '22.17', 'groupId': 'BG000', 'lowerLimit': '17.76', 'upperLimit': '28.74'}, {'value': '22.50', 'groupId': 'BG001', 'lowerLimit': '17.70', 'upperLimit': '28.46'}, {'value': '21.01', 'groupId': 'BG002', 'lowerLimit': '16.95', 'upperLimit': '24.35'}, {'value': '22.75', 'groupId': 'BG003', 'lowerLimit': '18.07', 'upperLimit': '27.12'}, {'value': '22.03', 'groupId': 'BG004', 'lowerLimit': '17.83', 'upperLimit': '27.19'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'μg/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Bone Specific Alkaline Phosphatase (BSAP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '251', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '14.49', 'groupId': 'BG000', 'lowerLimit': '12.26', 'upperLimit': '17.56'}, {'value': '13.92', 'groupId': 'BG001', 'lowerLimit': '11.53', 'upperLimit': '17.82'}, {'value': '15.49', 'groupId': 'BG002', 'lowerLimit': '11.85', 'upperLimit': '17.90'}, {'value': '14.72', 'groupId': 'BG003', 'lowerLimit': '11.45', 'upperLimit': '17.28'}, {'value': '14.72', 'groupId': 'BG004', 'lowerLimit': '11.85', 'upperLimit': '17.75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'μg/L', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Participants with available data'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 252}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'dispFirstSubmitDate': '2015-09-11', 'completionDateStruct': {'date': '2015-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-21', 'studyFirstSubmitDate': '2013-11-19', 'dispFirstSubmitQcDate': '2015-09-11', 'resultsFirstSubmitDate': '2018-11-20', 'studyFirstSubmitQcDate': '2013-11-19', 'dispFirstPostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-21', 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine', 'timeFrame': 'Baseline and 12 months', 'description': 'Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline at 6 Months in Bone Mineral Density at the Lumbar Spine', 'timeFrame': 'Baseline and 6 months', 'description': 'Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.'}, {'measure': 'Percent Change From Baseline at 6 Months in Bone Mineral Density at the Total Hip', 'timeFrame': 'Baseline and 6 months', 'description': 'Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.'}, {'measure': 'Percent Change From Baseline to 12 Months in Bone Mineral Density at the Total Hip', 'timeFrame': 'Baseline and 12 months', 'description': 'Bone density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.'}, {'measure': 'Percent Change From Baseline to 6 Months in Bone Mineral Density at the Femoral Neck', 'timeFrame': 'Baseline and 6 months', 'description': 'Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.'}, {'measure': 'Percent Change From Baseline to 12 Months in Bone Mineral Density at the Femoral Neck', 'timeFrame': 'Baseline and 12 months', 'description': 'Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.'}, {'measure': 'Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)', 'timeFrame': 'Baseline, week 1, and months 1, 2, 3, 6, 9, and 12'}, {'measure': 'Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)', 'timeFrame': 'Baseline, week 1, and months 1, 2, 3, 6, 9, and 12'}, {'measure': 'Percent Change From Baseline in Osteocalcin', 'timeFrame': 'Baseline, week 1, and months 1, 2, 3, 6, 9, and 12'}, {'measure': 'Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP)', 'timeFrame': 'Baseline, week 1, and months 1, 2, 3, 6, 9, and 12'}, {'measure': 'Area Under the Curve Through Month 12 of P1NP', 'timeFrame': 'Baseline, week 1 and months 1, 2, 3, 6, 9, and 12.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoporosis, Osteoporosis-Postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases'], 'conditions': ['Postmenopausal Osteoporosis (PMO)']}, 'referencesModule': {'references': [{'pmid': '28687496', 'type': 'BACKGROUND', 'citation': 'Ishibashi H, Crittenden DB, Miyauchi A, Libanati C, Maddox J, Fan M, Chen L, Grauer A. Romosozumab increases bone mineral density in postmenopausal Japanese women with osteoporosis: A phase 2 study. Bone. 2017 Oct;103:209-215. doi: 10.1016/j.bone.2017.07.005. Epub 2017 Jul 5.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if treatment with romosozumab increases bone mineral density in Japanese women with postmenopausal osteoporosis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAmbulatory, postmenopausal Japanese women with osteoporosis (defined as bone mineral density T-score of ≤ -4.00 at the lumbar spine or BMD T-score of ≤ -3.50 at the total hip, or femoral neck)\n\nExclusion Criteria:\n\n* Severe osteoporosis\n* Use of agents affecting bone metabolism\n* History of metabolic or bone disease (except osteoporosis)\n* Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)\n* Current hyper- or hypocalcemia\n* Current, uncontrolled hyper- or hypothyroidism\n* Current, uncontrolled hyper- or hypoparathyroidism'}, 'identificationModule': {'nctId': 'NCT01992159', 'briefTitle': 'Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis', 'orgStudyIdInfo': {'id': '20101291'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo matching to romosozumab administered by subcutaneous injection once a month for 12 months.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Romosozumab 70 mg', 'description': 'Participants received 70 mg romosozumab administered by subcutaneous injection once a month for 12 months.', 'interventionNames': ['Drug: Romosozumab']}, {'type': 'EXPERIMENTAL', 'label': 'Romosozumab 140 mg', 'description': 'Participants received 140 mg romosozumab administered by subcutaneous injection once a month for 12 months.', 'interventionNames': ['Drug: Romosozumab']}, {'type': 'EXPERIMENTAL', 'label': 'Romosozumab 210 mg', 'description': 'Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.', 'interventionNames': ['Drug: Romosozumab']}], 'interventions': [{'name': 'Romosozumab', 'type': 'DRUG', 'otherNames': ['AMG 785', 'EVENITY™'], 'description': 'Administered by subcutaneous injection', 'armGroupLabels': ['Romosozumab 140 mg', 'Romosozumab 210 mg', 'Romosozumab 70 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered by subcutaneous injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '446-0063', 'city': 'Anjyo-shi', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '814-0165', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '800-0057', 'city': 'Kitakyushu-shi', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '832-0059', 'city': 'Yanagawa-shi', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '509-6134', 'city': 'Mizunami-shi', 'state': 'Gifu', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '063-0814', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '065-0024', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '020-0066', 'city': 'Morioka', 'state': 'Iwate', 'country': 'Japan', 'facility': 'Research Site', 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'146-0094', 'city': 'Ōta-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.56126, 'lon': 139.71605}}, {'zip': '140-0011', 'city': 'Shinagawa-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '166-0003', 'city': 'Suginami-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '171-0033', 'city': 'Toshima-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site'}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}