Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-01-01 @ 7:06 PM
Study NCT ID:
NCT01059435
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2010-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A First-in-human Study Evaluating Romosozumab (AMG 785) in Healthy Men and Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'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': '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': 'Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.', 'description': 'Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo SC', 'description': 'Participants received a single subcutaneous (SC) injection of matching placebo.', 'otherNumAtRisk': 14, 'otherNumAffected': 9, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo IV', 'description': 'Participants received a single intravenous (IV) injection of matching placebo.', 'otherNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Romosozumab 0.1 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.', 'otherNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Romosozumab 0.3 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.', 'otherNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Romosozumab 1.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.', 'otherNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Romosozumab 10.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Romosozumab 3.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Romosozumab 5.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.', 'otherNumAtRisk': 9, 'otherNumAffected': 6, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Romosozumab 1.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 1.0 mg/kg romosozumab.', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Romosozumab 5.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 5.0 mg/kg romosozumab.', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'IRON DEFICIENCY ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': "BASEDOW'S DISEASE", 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'BLEPHARITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'CONJUNCTIVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'APHTHOUS STOMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'DRY MOUTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'LIP DRY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'ORAL DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'AXILLARY PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'INJECTION SITE ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'INJECTION SITE HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'INJECTION SITE REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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{'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo SC', 'description': 'Participants received a single subcutaneous (SC) injection of matching placebo.'}, {'id': 'OG001', 'title': 'Romosozumab 0.1 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.'}, {'id': 'OG002', 'title': 'Romosozumab 0.3 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.'}, {'id': 'OG003', 'title': 'Romosozumab 1.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG004', 'title': 'Romosozumab 3.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.'}, {'id': 'OG005', 'title': 'Romosozumab 5.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.'}, {'id': 'OG006', 'title': 'Romosozumab 10.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.'}, {'id': 'OG007', 'title': 'Placebo IV', 'description': 'Participants received a single intravenous (IV) injection of matching placebo.'}, {'id': 'OG008', 'title': 'Romosozumab 1.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG009', 'title': 'Romosozumab 5.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 5.0 mg/kg romosozumab'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Treatment-related adverse events', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}, {'title': 'Serious treatment-related adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Discontinuations due to adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.', 'description': 'Serious adverse events were any events that were fatal, were life-threatening (placed the participant at immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, were congenital anomalies or birth defects, or were other significant medical hazards.\n\nRelatedness to investigational product was assessed by the investigator by means of the question: "Is there a reasonable possibility that the event may have been caused by the investigational product?\'', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Developed Anti-romosozumab Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo SC', 'description': 'Participants received a single subcutaneous (SC) injection of matching placebo.'}, {'id': 'OG001', 'title': 'Romosozumab 0.1 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.'}, {'id': 'OG002', 'title': 'Romosozumab 0.3 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.'}, {'id': 'OG003', 'title': 'Romosozumab 1.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG004', 'title': 'Romosozumab 3.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.'}, {'id': 'OG005', 'title': 'Romosozumab 5.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.'}, {'id': 'OG006', 'title': 'Romosozumab 10.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.'}, {'id': 'OG007', 'title': 'Placebo IV', 'description': 'Participants received a single intravenous (IV) injection of matching placebo.'}, {'id': 'OG008', 'title': 'Romosozumab 1.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG009', 'title': 'Romosozumab 5.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 5.0 mg/kg romosozumab'}], 'classes': [{'title': 'Binding antibody positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}]}, {'title': 'Neutralizing antibody positive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 29 (all participants), day 57 (1, 3, 5, and 10 mg/kg treatment groups only) and at day 85 (5 and 10 mg/kg teatment groups only).', 'description': 'Binding anti-romosozumab antibody titers were assessed using a validated electrochemiluninescence (ECL) immunoassay. The limit of detection for this assay was 3.91 ng/mL of anti-romosozumab antibody in neat serum. Samples found to be positive for binding antibodies were further tested using a validated bioassay to determine if the antibodies were able to neutralize the activity of romosozumab. The limit of detection for this assay was ≥ 0.75 μg/mL.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Concentration (Cmax) of Romosozumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Romosozumab 0.1 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.'}, {'id': 'OG001', 'title': 'Romosozumab 0.3 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.'}, {'id': 'OG002', 'title': 'Romosozumab 1.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG003', 'title': 'Romosozumab 3.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.'}, {'id': 'OG004', 'title': 'Romosozumab 5.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.'}, {'id': 'OG005', 'title': 'Romosozumab 10.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.'}], 'classes': [{'categories': [{'measurements': [{'value': '375', 'spread': '182', 'groupId': 'OG000'}, {'value': '1280', 'spread': '653', 'groupId': 'OG001'}, {'value': '4890', 'spread': '1780', 'groupId': 'OG002'}, {'value': '21300', 'spread': '5170', 'groupId': 'OG003'}, {'value': '33500', 'spread': '8290', 'groupId': 'OG004'}, {'value': '75200', 'spread': '15900', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants who received subcutaneous romosozumab'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Observed Concentration (Tmax) of Romosozumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Romosozumab 0.1 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.'}, {'id': 'OG001', 'title': 'Romosozumab 0.3 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.'}, {'id': 'OG002', 'title': 'Romosozumab 1.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG003', 'title': 'Romosozumab 3.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.'}, {'id': 'OG004', 'title': 'Romosozumab 5.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.'}, {'id': 'OG005', 'title': 'Romosozumab 10.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '7'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '14'}, {'value': '5', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '7'}, {'value': '5', 'groupId': 'OG004', 'lowerLimit': '3', 'upperLimit': '7'}, {'value': '4.5', 'groupId': 'OG005', 'lowerLimit': '2', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants who received subcutaneous romosozumab'}, {'type': 'SECONDARY', 'title': 'Initial Concentration Following IV Administration (C0) of Romosozumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Romosozumab 1.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG001', 'title': 'Romosozumab 5.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 5.0 mg/kg romosozumab'}], 'classes': [{'categories': [{'measurements': [{'value': '24900', 'spread': '4670', 'groupId': 'OG000'}, {'value': '132000', 'spread': '13700', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 at the end of infusion', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants who received intravenously administered romosozumab'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-time Curve From Time Zero to Infinity for Romosozumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Romosozumab 0.1 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.'}, {'id': 'OG001', 'title': 'Romosozumab 0.3 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.'}, {'id': 'OG002', 'title': 'Romosozumab 1.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG003', 'title': 'Romosozumab 3.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.'}, {'id': 'OG004', 'title': 'Romosozumab 5.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.'}, {'id': 'OG005', 'title': 'Romosozumab 10.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.'}, {'id': 'OG006', 'title': 'Romosozumab 1.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG007', 'title': 'Romosozumab 5.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 5.0 mg/kg romosozumab'}], 'classes': [{'categories': [{'measurements': [{'value': '78.5', 'spread': '22.6', 'groupId': 'OG000'}, {'value': '288', 'spread': '144', 'groupId': 'OG001'}, {'value': '1480', 'spread': '605', 'groupId': 'OG002'}, {'value': '8170', 'spread': '1810', 'groupId': 'OG003'}, {'value': '16900', 'spread': '4350', 'groupId': 'OG004'}, {'value': '43400', 'spread': '8550', 'groupId': 'OG005'}, {'value': '3020', 'spread': '989', 'groupId': 'OG006'}, {'value': '24400', 'spread': '4400', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'unitOfMeasure': 'µg*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants who received romosozumab'}, {'type': 'SECONDARY', 'title': 'Apparent Clearance (CL/F) / Clearance (CL) for Romosozumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Romosozumab 0.1 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.'}, {'id': 'OG001', 'title': 'Romosozumab 0.3 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.'}, {'id': 'OG002', 'title': 'Romosozumab 1.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG003', 'title': 'Romosozumab 3.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.'}, {'id': 'OG004', 'title': 'Romosozumab 5.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.'}, {'id': 'OG005', 'title': 'Romosozumab 10.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.'}, {'id': 'OG006', 'title': 'Romosozumab 1.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG007', 'title': 'Romosozumab 5.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 5.0 mg/kg romosozumab'}], 'classes': [{'categories': [{'measurements': [{'value': '1.39', 'spread': '0.489', 'groupId': 'OG000'}, {'value': '1.35', 'spread': '0.841', 'groupId': 'OG001'}, {'value': '0.873', 'spread': '0.647', 'groupId': 'OG002'}, {'value': '0.383', 'spread': '0.0901', 'groupId': 'OG003'}, {'value': '0.319', 'spread': '0.0998', 'groupId': 'OG004'}, {'value': '0.236', 'spread': '0.0370', 'groupId': 'OG005'}, {'value': '0.362', 'spread': '0.117', 'groupId': 'OG006'}, {'value': '0.210', 'spread': '0.0361', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'unitOfMeasure': 'mL/hr/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants who received romosozumab'}, {'type': 'SECONDARY', 'title': 'Half-life Associated With the Beta (Plateau) Phase of Elimination for Romosozumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Romosozumab 0.1 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.'}, {'id': 'OG001', 'title': 'Romosozumab 0.3 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.'}, {'id': 'OG002', 'title': 'Romosozumab 1.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG003', 'title': 'Romosozumab 3.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.'}, {'id': 'OG004', 'title': 'Romosozumab 5.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.'}, {'id': 'OG005', 'title': 'Romosozumab 10.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.'}, {'id': 'OG006', 'title': 'Romosozumab 1.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG007', 'title': 'Romosozumab 5.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 5.0 mg/kg romosozumab'}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'spread': '3.70', 'groupId': 'OG003'}, {'value': '12.9', 'spread': '3.14', 'groupId': 'OG004'}, {'value': '18.0', 'spread': '3.54', 'groupId': 'OG005'}, {'value': '10.6', 'spread': '1.70', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'description': 'The plateau (beta, β) phase half-life (t½,β) was calculated from the natural log of 2 divided by the beta phase rate constant (λβ). λβ for a subject was estimated by linear regression of at least 3 contiguous time points that followed the Cmax and constituted a distinct phase that preceded the terminal phase.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants who received 3, 5, or 10 mg/kg romosozumab'}, {'type': 'SECONDARY', 'title': 'Half-life Associated With the Gamma (Terminal) Phase of Elimination for Romosozumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Romosozumab 0.1 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.'}, {'id': 'OG001', 'title': 'Romosozumab 0.3 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.'}, {'id': 'OG002', 'title': 'Romosozumab 1.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG003', 'title': 'Romosozumab 3.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.'}, {'id': 'OG004', 'title': 'Romosozumab 5.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.'}, {'id': 'OG005', 'title': 'Romosozumab 10.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.'}, {'id': 'OG006', 'title': 'Romosozumab 1.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG007', 'title': 'Romosozumab 5.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 5.0 mg/kg romosozumab'}], 'classes': [{'categories': [{'measurements': [{'value': '5.20', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '5.13', 'spread': '0.640', 'groupId': 'OG001'}, {'value': '5.50', 'spread': '0.322', 'groupId': 'OG002'}, {'value': '6.68', 'spread': '0.961', 'groupId': 'OG003'}, {'value': '5.81', 'spread': '0.874', 'groupId': 'OG004'}, {'value': '5.88', 'spread': '1.60', 'groupId': 'OG005'}, {'value': '4.49', 'spread': '0.974', 'groupId': 'OG006'}, {'value': '4.93', 'spread': '0.639', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'description': 'The 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participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'description': 'Defined as the maximum value postdose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Effect of P1NP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo SC', 'description': 'Participants received a single subcutaneous (SC) injection 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romosozumab.'}, {'id': 'OG009', 'title': 'Romosozumab 5.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 5.0 mg/kg romosozumab'}], 'classes': [{'categories': [{'measurements': [{'value': '462', 'spread': '157', 'groupId': 'OG000'}, {'value': '460', 'spread': '172', 'groupId': 'OG001'}, {'value': '460', 'spread': '127', 'groupId': 'OG002'}, {'value': '422', 'spread': '100', 'groupId': 'OG003'}, {'value': '588', 'spread': '152', 'groupId': 'OG004'}, {'value': '540', 'spread': '210', 'groupId': 'OG005'}, {'value': '639', 'spread': '176', 'groupId': 'OG006'}, {'value': '448', 'spread': '73', 'groupId': 'OG007'}, {'value': '376', 'spread': '102', 'groupId': 'OG008'}, {'value': '780', 'spread': '325', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'unitOfMeasure': 'days*µg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for BSAP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo SC', 'description': 'Participants received a single subcutaneous (SC) injection of matching placebo.'}, {'id': 'OG001', 'title': 'Romosozumab 0.1 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.'}, {'id': 'OG002', 'title': 'Romosozumab 0.3 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.'}, {'id': 'OG003', 'title': 'Romosozumab 1.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG004', 'title': 'Romosozumab 3.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.'}, {'id': 'OG005', 'title': 'Romosozumab 5.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.'}, {'id': 'OG006', 'title': 'Romosozumab 10.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.'}, {'id': 'OG007', 'title': 'Placebo IV', 'description': 'Participants received a single intravenous (IV) injection of matching placebo.'}, {'id': 'OG008', 'title': 'Romosozumab 1.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG009', 'title': 'Romosozumab 5.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 5.0 mg/kg romosozumab'}], 'classes': [{'categories': [{'measurements': [{'value': '958', 'spread': '428', 'groupId': 'OG000'}, {'value': '460', 'spread': '172', 'groupId': 'OG001'}, {'value': '460', 'spread': '127', 'groupId': 'OG002'}, {'value': '815', 'spread': '190', 'groupId': 'OG003'}, {'value': '1120', 'spread': '303', 'groupId': 'OG004'}, {'value': '1496', 'spread': '527', 'groupId': 'OG005'}, {'value': '1860', 'spread': '508', 'groupId': 'OG006'}, {'value': '1138', 'spread': '191', 'groupId': 'OG007'}, {'value': '731', 'spread': '177', 'groupId': 'OG008'}, {'value': '2033', 'spread': '780', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'unitOfMeasure': 'days*µg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Maximum Effect for Intact Parathyroid Hormone (iPTH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo SC', 'description': 'Participants received a single subcutaneous (SC) injection of matching placebo.'}, {'id': 'OG001', 'title': 'Romosozumab 0.1 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.'}, {'id': 'OG002', 'title': 'Romosozumab 0.3 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.'}, {'id': 'OG003', 'title': 'Romosozumab 1.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG004', 'title': 'Romosozumab 3.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.'}, {'id': 'OG005', 'title': 'Romosozumab 5.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.'}, {'id': 'OG006', 'title': 'Romosozumab 10.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.'}, {'id': 'OG007', 'title': 'Placebo IV', 'description': 'Participants received a single intravenous (IV) injection of matching placebo.'}, {'id': 'OG008', 'title': 'Romosozumab 1.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG009', 'title': 'Romosozumab 5.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 5.0 mg/kg romosozumab'}], 'classes': [{'categories': [{'measurements': [{'value': '43.3', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '38.7', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '54.5', 'spread': '13.1', 'groupId': 'OG002'}, {'value': '49.9', 'spread': '20.5', 'groupId': 'OG003'}, {'value': '62.8', 'spread': '10.9', 'groupId': 'OG004'}, {'value': '66.0', 'spread': '20.0', 'groupId': 'OG005'}, {'value': '76.3', 'spread': '15.7', 'groupId': 'OG006'}, {'value': '64.8', 'spread': '27.8', 'groupId': 'OG007'}, {'value': '52.7', 'spread': '20.1', 'groupId': 'OG008'}, {'value': '59.7', 'spread': '14.9', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'description': 'Defined as the maximum value postdose.', 'unitOfMeasure': 'ng/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Effect of iPTH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo SC', 'description': 'Participants received a single subcutaneous (SC) injection of matching placebo.'}, {'id': 'OG001', 'title': 'Romosozumab 0.1 mg/kg 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'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo SC', 'description': 'Participants received a single subcutaneous (SC) injection of matching placebo.'}, {'id': 'OG001', 'title': 'Romosozumab 0.1 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.'}, {'id': 'OG002', 'title': 'Romosozumab 0.3 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.'}, {'id': 'OG003', 'title': 'Romosozumab 1.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG004', 'title': 'Romosozumab 3.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.'}, {'id': 'OG005', 'title': 'Romosozumab 5.0 mg/kg SC', 'description': 'Participants 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'1240', 'spread': '342', 'groupId': 'OG005'}, {'value': '1422', 'spread': '411', 'groupId': 'OG006'}, {'value': '1235', 'spread': '488', 'groupId': 'OG007'}, {'value': '1074', 'spread': '406', 'groupId': 'OG008'}, {'value': '1239', 'spread': '267', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'unitOfMeasure': 'days*ng/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Day 0 to the Last Sampling Timepoint (AUC0-t) for iPTH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo SC', 'description': 'Participants received a single subcutaneous (SC) injection of matching placebo.'}, {'id': 'OG001', 'title': 'Romosozumab 0.1 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.'}, {'id': 'OG002', 'title': 'Romosozumab 0.3 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.'}, {'id': 'OG003', 'title': 'Romosozumab 1.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG004', 'title': 'Romosozumab 3.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.'}, {'id': 'OG005', 'title': 'Romosozumab 5.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.'}, {'id': 'OG006', 'title': 'Romosozumab 10.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.'}, {'id': 'OG007', 'title': 'Placebo IV', 'description': 'Participants received a single intravenous (IV) injection of matching placebo.'}, {'id': 'OG008', 'title': 'Romosozumab 1.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG009', 'title': 'Romosozumab 5.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 5.0 mg/kg romosozumab'}], 'classes': [{'categories': [{'measurements': [{'value': '1592', 'spread': '689', 'groupId': 'OG000'}, {'value': '823', 'spread': '202', 'groupId': 'OG001'}, {'value': '1234', 'spread': '341', 'groupId': 'OG002'}, {'value': '1971', 'spread': '850', 'groupId': 'OG003'}, {'value': '2523', 'spread': '406', 'groupId': 'OG004'}, {'value': '3483', 'spread': '1057', 'groupId': 'OG005'}, {'value': '4195', 'spread': '1144', 'groupId': 'OG006'}, {'value': '3100', 'spread': '1077', 'groupId': 'OG007'}, {'value': '2072', 'spread': '749', 'groupId': 'OG008'}, {'value': '3515', 'spread': '1127', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'unitOfMeasure': 'days*ng/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Sclerostin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo SC', 'description': 'Participants received a single subcutaneous (SC) injection of matching placebo.'}, {'id': 'OG001', 'title': 'Romosozumab 0.1 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.'}, {'id': 'OG002', 'title': 'Romosozumab 0.3 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.'}, {'id': 'OG003', 'title': 'Romosozumab 1.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG004', 'title': 'Romosozumab 3.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.'}, {'id': 'OG005', 'title': 'Romosozumab 5.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.'}, {'id': 'OG006', 'title': 'Romosozumab 10.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.'}, {'id': 'OG007', 'title': 'Placebo IV', 'description': 'Participants received a single intravenous (IV) injection of matching placebo.'}, {'id': 'OG008', 'title': 'Romosozumab 1.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG009', 'title': 'Romosozumab 5.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 5.0 mg/kg romosozumab'}], 'classes': [{'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '53.2', 'spread': '54.3', 'groupId': 'OG000'}, {'value': '465.5', 'spread': '49.9', 'groupId': 'OG001'}, {'value': '835.1', 'spread': '130.4', 'groupId': 'OG002'}, {'value': '2123.8', 'spread': '377.6', 'groupId': 'OG003'}, {'value': '7965.9', 'spread': '792.9', 'groupId': 'OG004'}, {'value': '12375.7', 'spread': '1375.4', 'groupId': 'OG005'}, {'value': '17774.8', 'spread': '2444.0', 'groupId': 'OG006'}, {'value': '6.7', 'spread': '11.4', 'groupId': 'OG007'}, {'value': '3776.0', 'spread': '461.5', 'groupId': 'OG008'}, {'value': '14230.0', 'spread': '2428.1', 'groupId': 'OG009'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-8.4', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '129.0', 'spread': '33.3', 'groupId': 'OG001'}, {'value': '183.0', 'spread': '19.6', 'groupId': 'OG002'}, {'value': '717.4', 'spread': '92.4', 'groupId': 'OG003'}, {'value': '5140.2', 'spread': '373.7', 'groupId': 'OG004'}, {'value': '9763.2', 'spread': '1252.8', 'groupId': 'OG005'}, {'value': '18870.9', 'spread': '2707.3', 'groupId': 'OG006'}, {'value': '-4.3', 'spread': '8.7', 'groupId': 'OG007'}, {'value': '816.7', 'spread': '222.3', 'groupId': 'OG008'}, {'value': '11715.5', 'spread': '2177.0', 'groupId': 'OG009'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-9.8', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '223.2', 'spread': '18.1', 'groupId': 'OG003'}, {'value': '1988.3', 'spread': '339.9', 'groupId': 'OG004'}, {'value': '4968.7', 'spread': '714.7', 'groupId': 'OG005'}, {'value': '13902.7', 'spread': '2381.9', 'groupId': 'OG006'}, {'value': '4.9', 'spread': '8.7', 'groupId': 'OG007'}, {'value': '196.1', 'spread': '48.7', 'groupId': 'OG008'}, {'value': '4576.0', 'spread': '1086.7', 'groupId': 'OG009'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '83.4', 'spread': '14.5', 'groupId': 'OG003'}, {'value': '810.2', 'spread': '169.9', 'groupId': 'OG004'}, {'value': '2004.9', 'spread': '421.5', 'groupId': 'OG005'}, {'value': '6469.6', 'spread': '1000.3', 'groupId': 'OG006'}, {'value': '15.6', 'spread': '0.6', 'groupId': 'OG007'}, {'value': '49.9', 'spread': '17.4', 'groupId': 'OG008'}, {'value': '1430.0', 'spread': '538.0', 'groupId': 'OG009'}]}]}, {'title': 'Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '86.9', 'spread': '88.3', 'groupId': 'OG000'}, {'value': '610.4', 'spread': '151.6', 'groupId': 'OG005'}, {'value': '2080.8', 'spread': '689.0', 'groupId': 'OG006'}, {'value': '-5.5', 'spread': '5.4', 'groupId': 'OG007'}, {'value': '426.9', 'spread': '119.6', 'groupId': 'OG009'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '11.6', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '232.1', 'spread': '49.0', 'groupId': 'OG005'}, {'value': '758.0', 'spread': '270.1', 'groupId': 'OG006'}, {'value': '0.8', 'spread': '13.4', 'groupId': 'OG007'}, {'value': '109.8', 'spread': '30.6', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and days 15, 29, 43, 57, 71, and 85', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants; only participants who received ≥ 1 mg/kg romosozumab/placebo were assessed after day 29 and only participants who received 5 or 10 mg/kg romosozumab/placebo were assessed on days 71 and 85.'}, {'type': 'SECONDARY', 'title': 'Serum Calcium Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo SC', 'description': 'Participants received a single subcutaneous (SC) injection of matching placebo.'}, {'id': 'OG001', 'title': 'Romosozumab 0.1 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.'}, {'id': 'OG002', 'title': 'Romosozumab 0.3 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.'}, {'id': 'OG003', 'title': 'Romosozumab 1.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG004', 'title': 'Romosozumab 3.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.'}, {'id': 'OG005', 'title': 'Romosozumab 5.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.'}, {'id': 'OG006', 'title': 'Romosozumab 10.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.'}, {'id': 'OG007', 'title': 'Placebo IV', 'description': 'Participants received a single intravenous (IV) injection of matching placebo.'}, {'id': 'OG008', 'title': 'Romosozumab 1.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG009', 'title': 'Romosozumab 5.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 5.0 mg/kg romosozumab'}], 'classes': [{'title': 'Day 1 Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.49', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '9.45', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '9.50', 'spread': '0.33', 'groupId': 'OG002'}, {'value': '9.48', 'spread': '0.27', 'groupId': 'OG003'}, {'value': '9.42', 'spread': '0.25', 'groupId': 'OG004'}, {'value': '9.53', 'spread': '0.26', 'groupId': 'OG005'}, {'value': '9.38', 'spread': '0.24', 'groupId': 'OG006'}, {'value': '9.60', 'spread': '0.22', 'groupId': 'OG007'}, {'value': '9.23', 'spread': '0.15', 'groupId': 'OG008'}, {'value': '9.37', 'spread': '0.15', 'groupId': 'OG009'}]}]}, {'title': 'Day 1 Hour 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.46', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '9.62', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '9.45', 'spread': '0.26', 'groupId': 'OG002'}, {'value': '9.38', 'spread': '0.16', 'groupId': 'OG003'}, {'value': '9.38', 'spread': '0.15', 'groupId': 'OG004'}, {'value': '9.59', 'spread': '0.27', 'groupId': 'OG005'}, {'value': '9.35', 'spread': '0.40', 'groupId': 'OG006'}, {'value': '9.45', 'spread': '0.21', 'groupId': 'OG007'}, {'value': '9.43', 'spread': '0.22', 'groupId': 'OG008'}, {'value': '9.40', 'spread': '0.17', 'groupId': 'OG009'}]}]}, {'title': 'Day 1 Hour 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.49', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '9.38', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '9.50', 'spread': '0.14', 'groupId': 'OG002'}, {'value': '9.47', 'spread': '0.17', 'groupId': 'OG003'}, {'value': '9.60', 'spread': '0.24', 'groupId': 'OG004'}, {'value': '9.48', 'spread': '0.35', 'groupId': 'OG005'}, {'value': '9.25', 'spread': '0.36', 'groupId': 'OG006'}, {'value': '9.18', 'spread': '0.13', 'groupId': 'OG007'}, {'value': '9.38', 'spread': '0.31', 'groupId': 'OG008'}, {'value': '9.40', 'spread': '0.15', 'groupId': 'OG009'}]}]}, {'title': 'Day 1 Hour 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.38', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '9.47', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '9.33', 'spread': '0.23', 'groupId': 'OG002'}, {'value': '9.29', 'spread': '0.18', 'groupId': 'OG003'}, {'value': '9.28', 'spread': '0.12', 'groupId': 'OG004'}, {'value': '9.42', 'spread': '0.28', 'groupId': 'OG005'}, {'value': '9.27', 'spread': '0.33', 'groupId': 'OG006'}, {'value': '9.38', 'spread': '0.21', 'groupId': 'OG007'}, {'value': '9.35', 'spread': '0.10', 'groupId': 'OG008'}, {'value': '9.22', 'spread': '0.12', 'groupId': 'OG009'}]}]}, {'title': 'Day 1 Hour 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.53', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '9.62', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '9.50', 'spread': '0.27', 'groupId': 'OG002'}, {'value': '9.40', 'spread': '0.30', 'groupId': 'OG003'}, {'value': '9.38', 'spread': '0.19', 'groupId': 'OG004'}, {'value': '9.36', 'spread': '0.31', 'groupId': 'OG005'}, {'value': '9.28', 'spread': '0.27', 'groupId': 'OG006'}, {'value': '9.50', 'spread': '0.22', 'groupId': 'OG007'}, {'value': '9.45', 'spread': '0.16', 'groupId': 'OG008'}, {'value': '9.42', 'spread': '0.15', 'groupId': 'OG009'}]}]}, {'title': 'Day 1 Hour 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.53', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '9.55', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '9.57', 'spread': '0.31', 'groupId': 'OG002'}, {'value': '9.49', 'spread': '0.31', 'groupId': 'OG003'}, {'value': '9.37', 'spread': '0.34', 'groupId': 'OG004'}, {'value': '9.52', 'spread': '0.26', 'groupId': 'OG005'}, {'value': '9.27', 'spread': '0.34', 'groupId': 'OG006'}, {'value': '9.40', 'spread': '0.24', 'groupId': 'OG007'}, {'value': '9.47', 'spread': '0.19', 'groupId': 'OG008'}, {'value': '9.45', 'spread': '0.19', 'groupId': 'OG009'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.46', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '9.55', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '9.23', 'spread': '0.28', 'groupId': 'OG002'}, {'value': '9.39', 'spread': '0.21', 'groupId': 'OG003'}, {'value': '9.37', 'spread': '0.33', 'groupId': 'OG004'}, {'value': '9.46', 'spread': '0.29', 'groupId': 'OG005'}, {'value': '9.23', 'spread': '0.29', 'groupId': 'OG006'}, {'value': '8.55', 'spread': '1.77', 'groupId': 'OG007'}, {'value': '9.05', 'spread': '0.41', 'groupId': 'OG008'}, {'value': '9.28', 'spread': '0.15', 'groupId': 'OG009'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.30', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '9.37', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '9.25', 'spread': '0.39', 'groupId': 'OG002'}, {'value': '9.20', 'spread': '0.34', 'groupId': 'OG003'}, {'value': '9.35', 'spread': '0.14', 'groupId': 'OG004'}, {'value': '9.38', 'spread': '0.41', 'groupId': 'OG005'}, {'value': '9.18', 'spread': '0.17', 'groupId': 'OG006'}, {'value': '9.40', 'spread': '0.24', 'groupId': 'OG007'}, {'value': '9.13', 'spread': '0.51', 'groupId': 'OG008'}, {'value': '9.27', 'spread': '0.18', 'groupId': 'OG009'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.49', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '9.38', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '9.37', 'spread': '0.27', 'groupId': 'OG002'}, {'value': '9.18', 'spread': '0.64', 'groupId': 'OG003'}, {'value': '9.27', 'spread': '0.12', 'groupId': 'OG004'}, {'value': '9.40', 'spread': '0.30', 'groupId': 'OG005'}, {'value': '9.13', 'spread': '0.22', 'groupId': 'OG006'}, {'value': '9.23', 'spread': '0.50', 'groupId': 'OG007'}, {'value': '8.88', 'spread': '0.84', 'groupId': 'OG008'}, {'value': '9.18', 'spread': '0.13', 'groupId': 'OG009'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.42', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '9.38', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '9.37', 'spread': '0.25', 'groupId': 'OG002'}, {'value': '9.38', 'spread': '0.24', 'groupId': 'OG003'}, {'value': '9.32', 'spread': '0.25', 'groupId': 'OG004'}, {'value': '9.24', 'spread': '0.26', 'groupId': 'OG005'}, {'value': '9.15', 'spread': '0.18', 'groupId': 'OG006'}, {'value': '9.55', 'spread': '0.17', 'groupId': 'OG007'}, {'value': '9.20', 'spread': '0.15', 'groupId': 'OG008'}, {'value': '9.12', 'spread': '0.19', 'groupId': 'OG009'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.56', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '9.45', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '9.45', 'spread': '0.26', 'groupId': 'OG002'}, {'value': '9.51', 'spread': '0.20', 'groupId': 'OG003'}, {'value': '9.35', 'spread': '0.10', 'groupId': 'OG004'}, {'value': '9.36', 'spread': '0.26', 'groupId': 'OG005'}, {'value': '9.18', 'spread': '0.15', 'groupId': 'OG006'}, {'value': '9.35', 'spread': '0.24', 'groupId': 'OG007'}, {'value': '9.32', 'spread': '0.19', 'groupId': 'OG008'}, {'value': '9.23', 'spread': '0.12', 'groupId': 'OG009'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.41', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '9.45', 'spread': '0.20', 'groupId': 'OG001'}, {'value': '9.28', 'spread': '0.23', 'groupId': 'OG002'}, {'value': '9.36', 'spread': '0.44', 'groupId': 'OG003'}, {'value': '9.23', 'spread': '0.10', 'groupId': 'OG004'}, {'value': '9.33', 'spread': '0.40', 'groupId': 'OG005'}, {'value': '8.93', 'spread': '0.28', 'groupId': 'OG006'}, {'value': '9.30', 'spread': '0.22', 'groupId': 'OG007'}, {'value': '9.18', 'spread': '0.29', 'groupId': 'OG008'}, {'value': '9.20', 'spread': '0.37', 'groupId': 'OG009'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.32', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '9.38', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '9.07', 'spread': '0.24', 'groupId': 'OG002'}, {'value': '9.39', 'spread': '0.25', 'groupId': 'OG003'}, {'value': '9.30', 'spread': '0.39', 'groupId': 'OG004'}, {'value': '9.19', 'spread': '0.36', 'groupId': 'OG005'}, {'value': '8.70', 'spread': '0.75', 'groupId': 'OG006'}, {'value': '9.30', 'spread': '0.22', 'groupId': 'OG007'}, {'value': '9.13', 'spread': '0.29', 'groupId': 'OG008'}, {'value': '9.18', 'spread': '0.26', 'groupId': 'OG009'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.39', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '9.60', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '9.40', 'spread': '0.32', 'groupId': 'OG002'}, {'value': '9.26', 'spread': '0.21', 'groupId': 'OG003'}, {'value': '9.22', 'spread': '0.19', 'groupId': 'OG004'}, {'value': '9.06', 'spread': '0.35', 'groupId': 'OG005'}, {'value': '8.97', 'spread': '0.18', 'groupId': 'OG006'}, {'value': '9.33', 'spread': '0.22', 'groupId': 'OG007'}, {'value': '9.28', 'spread': '0.33', 'groupId': 'OG008'}, {'value': '9.00', 'spread': '0.36', 'groupId': 'OG009'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.35', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '9.53', 'spread': '0.45', 'groupId': 'OG001'}, {'value': '9.18', 'spread': '0.35', 'groupId': 'OG002'}, {'value': '9.33', 'spread': '0.32', 'groupId': 'OG003'}, {'value': '9.22', 'spread': '0.17', 'groupId': 'OG004'}, {'value': '9.14', 'spread': '0.47', 'groupId': 'OG005'}, {'value': '8.90', 'spread': '0.23', 'groupId': 'OG006'}, {'value': '9.48', 'spread': '0.13', 'groupId': 'OG007'}, {'value': '9.18', 'spread': '0.22', 'groupId': 'OG008'}, {'value': '9.08', 'spread': '0.15', 'groupId': 'OG009'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.49', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '9.58', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '9.40', 'spread': '0.26', 'groupId': 'OG002'}, {'value': '9.44', 'spread': '0.37', 'groupId': 'OG003'}, {'value': '9.20', 'spread': '0.27', 'groupId': 'OG004'}, {'value': '9.32', 'spread': '0.28', 'groupId': 'OG005'}, {'value': '8.95', 'spread': '0.19', 'groupId': 'OG006'}, {'value': '9.38', 'spread': '0.13', 'groupId': 'OG007'}, {'value': '9.17', 'spread': '0.21', 'groupId': 'OG008'}, {'value': '9.15', 'spread': '0.23', 'groupId': 'OG009'}]}]}, {'title': 'Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.40', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '9.33', 'spread': '0.26', 'groupId': 'OG003'}, {'value': '9.23', 'spread': '0.30', 'groupId': 'OG004'}, {'value': '9.00', 'spread': '0.26', 'groupId': 'OG005'}, {'value': '9.07', 'spread': '0.26', 'groupId': 'OG006'}, {'value': '9.25', 'spread': '0.30', 'groupId': 'OG007'}, {'value': '9.18', 'spread': '0.35', 'groupId': 'OG008'}, {'value': '9.00', 'spread': '0.30', 'groupId': 'OG009'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.33', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '9.32', 'spread': '0.21', 'groupId': 'OG003'}, {'value': '9.37', 'spread': '0.31', 'groupId': 'OG004'}, {'value': '9.23', 'spread': '0.36', 'groupId': 'OG005'}, {'value': '8.90', 'spread': '0.26', 'groupId': 'OG006'}, {'value': '9.28', 'spread': '0.33', 'groupId': 'OG007'}, {'value': '9.25', 'spread': '0.25', 'groupId': 'OG008'}, {'value': '9.15', 'spread': '0.33', 'groupId': 'OG009'}]}]}, {'title': 'Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.35', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '9.30', 'spread': '0.41', 'groupId': 'OG003'}, {'value': '9.03', 'spread': '0.21', 'groupId': 'OG004'}, {'value': '9.40', 'spread': '0.34', 'groupId': 'OG005'}, {'value': '8.98', 'spread': '0.19', 'groupId': 'OG006'}, {'value': '9.33', 'spread': '0.33', 'groupId': 'OG007'}, {'value': '9.43', 'spread': '0.50', 'groupId': 'OG008'}, {'value': '9.07', 'spread': '0.23', 'groupId': 'OG009'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.46', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '9.47', 'spread': '0.36', 'groupId': 'OG003'}, {'value': '9.35', 'spread': '0.29', 'groupId': 'OG004'}, {'value': '9.18', 'spread': '0.49', 'groupId': 'OG005'}, {'value': '9.28', 'spread': '0.17', 'groupId': 'OG006'}, {'value': '9.33', 'spread': '0.29', 'groupId': 'OG007'}, {'value': '9.25', 'spread': '0.27', 'groupId': 'OG008'}, {'value': '9.02', 'spread': '0.21', 'groupId': 'OG009'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.22', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '9.28', 'spread': '0.42', 'groupId': 'OG005'}, {'value': '8.90', 'spread': '0.36', 'groupId': 'OG006'}, {'value': '9.25', 'spread': '0.07', 'groupId': 'OG007'}, {'value': '9.18', 'spread': '0.35', 'groupId': 'OG009'}]}]}, {'title': 'Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.36', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '9.47', 'spread': '0.47', 'groupId': 'OG005'}, {'value': '9.05', 'spread': '0.36', 'groupId': 'OG006'}, {'value': '9.20', 'spread': '0.14', 'groupId': 'OG007'}, {'value': '9.20', 'spread': '0.14', 'groupId': 'OG009'}]}]}, {'title': 'Day 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.30', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '9.31', 'spread': '0.32', 'groupId': 'OG005'}, {'value': '9.07', 'spread': '0.40', 'groupId': 'OG006'}, {'value': '9.20', 'spread': '0.00', 'groupId': 'OG007'}, {'value': '9.12', 'spread': '0.34', 'groupId': 'OG009'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '9.12', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '9.47', 'spread': '0.35', 'groupId': 'OG005'}, {'value': '8.82', 'spread': '0.31', 'groupId': 'OG006'}, {'value': '9.10', 'spread': '0.28', 'groupId': 'OG007'}, {'value': '9.05', 'spread': '0.26', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Dday 1 predose and at 4, 6, 8, 10, and 12 hours, days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants; only participants who received ≥ 1 mg/kg romosozumab/placebo were assessed after day 29 and only participants who received 5 or 10 mg/kg romosozumab/placebo were assessed after day 57.'}, {'type': 'SECONDARY', 'title': 'Ionized Calcium Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo SC', 'description': 'Participants received a single subcutaneous (SC) injection of matching placebo.'}, {'id': 'OG001', 'title': 'Romosozumab 0.1 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.'}, {'id': 'OG002', 'title': 'Romosozumab 0.3 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.'}, {'id': 'OG003', 'title': 'Romosozumab 1.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG004', 'title': 'Romosozumab 3.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.'}, {'id': 'OG005', 'title': 'Romosozumab 5.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.'}, {'id': 'OG006', 'title': 'Romosozumab 10.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.'}, {'id': 'OG007', 'title': 'Placebo IV', 'description': 'Participants received a single intravenous (IV) injection of matching placebo.'}, {'id': 'OG008', 'title': 'Romosozumab 1.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 1.0 mg/kg romosozumab.'}, {'id': 'OG009', 'title': 'Romosozumab 5.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 5.0 mg/kg romosozumab'}], 'classes': [{'title': 'Day 1 Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5.02', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '4.95', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '5.02', 'spread': '0.16', 'groupId': 'OG002'}, {'value': '5.01', 'spread': '0.18', 'groupId': 'OG003'}, {'value': '4.88', 'spread': '0.08', 'groupId': 'OG004'}, {'value': '5.07', 'spread': '0.18', 'groupId': 'OG005'}, {'value': '4.85', 'spread': '0.10', 'groupId': 'OG006'}, {'value': '5.30', 'spread': '0.12', 'groupId': 'OG007'}, {'value': '5.18', 'spread': '0.15', 'groupId': 'OG008'}, {'value': '5.27', 'spread': '0.15', 'groupId': 'OG009'}]}]}, {'title': 'Day 1 Hour 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5.06', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '5.02', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '5.10', 'spread': '0.13', 'groupId': 'OG002'}, {'value': '5.11', 'spread': '0.24', 'groupId': 'OG003'}, {'value': '5.03', 'spread': '0.10', 'groupId': 'OG004'}, {'value': '5.12', 'spread': '0.32', 'groupId': 'OG005'}, {'value': '4.95', 'spread': '0.08', 'groupId': 'OG006'}, {'value': '5.40', 'spread': '0.14', 'groupId': 'OG007'}, {'value': '5.35', 'spread': '0.18', 'groupId': 'OG008'}, {'value': '5.40', 'spread': '0.09', 'groupId': 'OG009'}]}]}, {'title': 'Day 1 Hour 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '4.97', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '4.93', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '4.98', 'spread': '0.10', 'groupId': 'OG002'}, {'value': '4.97', 'spread': '0.21', 'groupId': 'OG003'}, {'value': '4.93', 'spread': '0.08', 'groupId': 'OG004'}, {'value': '5.06', 'spread': '0.24', 'groupId': 'OG005'}, {'value': '4.87', 'spread': '0.12', 'groupId': 'OG006'}, {'value': '5.10', 'spread': '0.14', 'groupId': 'OG007'}, {'value': '5.28', 'spread': '0.15', 'groupId': 'OG008'}, {'value': '5.30', 'spread': '0.09', 'groupId': 'OG009'}]}]}, {'title': 'Day 1 Hour 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '4.93', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '4.92', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '5.00', 'spread': '0.11', 'groupId': 'OG002'}, {'value': '5.00', 'spread': '0.21', 'groupId': 'OG003'}, {'value': '4.90', 'spread': '0.06', 'groupId': 'OG004'}, {'value': '5.04', 'spread': '0.27', 'groupId': 'OG005'}, {'value': '4.78', 'spread': '0.12', 'groupId': 'OG006'}, {'value': '5.30', 'spread': '0.08', 'groupId': 'OG007'}, {'value': '5.28', 'spread': '0.17', 'groupId': 'OG008'}, {'value': '5.30', 'spread': '0.09', 'groupId': 'OG009'}]}]}, {'title': 'Day 1 Hour 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5.06', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '5.05', 'spread': '0.10', 'groupId': 'OG002'}, {'value': '5.11', 'spread': '0.19', 'groupId': 'OG003'}, {'value': '4.95', 'spread': '0.15', 'groupId': 'OG004'}, {'value': '5.07', 'spread': '0.34', 'groupId': 'OG005'}, {'value': '4.88', 'spread': '0.12', 'groupId': 'OG006'}, {'value': '5.30', 'spread': '0.12', 'groupId': 'OG007'}, {'value': '5.32', 'spread': '0.18', 'groupId': 'OG008'}, {'value': '5.38', 'spread': '0.15', 'groupId': 'OG009'}]}]}, {'title': 'Day 1 Hour 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5.01', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '4.95', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '5.00', 'spread': '0.15', 'groupId': 'OG002'}, {'value': '5.01', 'spread': '0.20', 'groupId': 'OG003'}, {'value': '4.93', 'spread': '0.16', 'groupId': 'OG004'}, {'value': '5.03', 'spread': '0.30', 'groupId': 'OG005'}, {'value': '4.80', 'spread': '0.11', 'groupId': 'OG006'}, {'value': '5.28', 'spread': '0.22', 'groupId': 'OG007'}, {'value': '5.25', 'spread': '0.10', 'groupId': 'OG008'}, {'value': '5.33', 'spread': '0.08', 'groupId': 'OG009'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5.04', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '5.03', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '4.92', 'spread': '0.17', 'groupId': 'OG002'}, {'value': '5.03', 'spread': '0.17', 'groupId': 'OG003'}, {'value': '4.98', 'spread': '0.12', 'groupId': 'OG004'}, {'value': '5.04', 'spread': '0.19', 'groupId': 'OG005'}, {'value': '4.88', 'spread': '0.15', 'groupId': 'OG006'}, {'value': '5.28', 'spread': '0.10', 'groupId': 'OG007'}, {'value': '5.08', 'spread': '0.08', 'groupId': 'OG008'}, {'value': '5.18', 'spread': '0.10', 'groupId': 'OG009'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5.06', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '4.97', 'spread': '0.14', 'groupId': 'OG002'}, {'value': '5.00', 'spread': '0.14', 'groupId': 'OG003'}, {'value': '4.95', 'spread': '0.08', 'groupId': 'OG004'}, {'value': '5.12', 'spread': '0.20', 'groupId': 'OG005'}, {'value': '4.85', 'spread': '0.05', 'groupId': 'OG006'}, {'value': '5.28', 'spread': '0.13', 'groupId': 'OG007'}, {'value': '5.17', 'spread': '0.12', 'groupId': 'OG008'}, {'value': '5.25', 'spread': '0.14', 'groupId': 'OG009'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5.05', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '4.97', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '4.85', 'spread': '0.16', 'groupId': 'OG002'}, {'value': '5.03', 'spread': '0.10', 'groupId': 'OG003'}, {'value': '4.87', 'spread': '0.12', 'groupId': 'OG004'}, {'value': '5.11', 'spread': '0.20', 'groupId': 'OG005'}, {'value': '4.82', 'spread': '0.08', 'groupId': 'OG006'}, {'value': '5.23', 'spread': '0.17', 'groupId': 'OG007'}, {'value': '5.20', 'spread': '0.09', 'groupId': 'OG008'}, {'value': '5.17', 'spread': '0.14', 'groupId': 'OG009'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5.02', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '4.93', 'spread': '0.10', 'groupId': 'OG001'}, {'value': '4.88', 'spread': '0.25', 'groupId': 'OG002'}, {'value': '5.04', 'spread': '0.12', 'groupId': 'OG003'}, {'value': '4.93', 'spread': '0.12', 'groupId': 'OG004'}, {'value': '5.04', 'spread': '0.19', 'groupId': 'OG005'}, {'value': '4.80', 'spread': '0.06', 'groupId': 'OG006'}, {'value': '5.40', 'spread': '0.14', 'groupId': 'OG007'}, {'value': '5.18', 'spread': '0.12', 'groupId': 'OG008'}, {'value': '5.15', 'spread': '0.14', 'groupId': 'OG009'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5.02', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '4.91', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '4.97', 'spread': '0.12', 'groupId': 'OG002'}, {'value': '5.06', 'spread': '0.11', 'groupId': 'OG003'}, {'value': '4.88', 'spread': '0.10', 'groupId': 'OG004'}, {'value': '5.02', 'spread': '0.14', 'groupId': 'OG005'}, {'value': '4.80', 'spread': '0.06', 'groupId': 'OG006'}, {'value': '5.23', 'spread': '0.10', 'groupId': 'OG007'}, {'value': '5.23', 'spread': '0.12', 'groupId': 'OG008'}, {'value': '5.05', 'spread': '0.10', 'groupId': 'OG009'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5.02', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '4.98', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '4.92', 'spread': '0.10', 'groupId': 'OG002'}, {'value': '5.01', 'spread': '0.24', 'groupId': 'OG003'}, {'value': '4.83', 'spread': '0.10', 'groupId': 'OG004'}, {'value': '4.89', 'spread': '0.18', 'groupId': 'OG005'}, {'value': '5.00', 'spread': '0.14', 'groupId': 'OG006'}, {'value': '5.23', 'spread': '0.17', 'groupId': 'OG007'}, {'value': '5.17', 'spread': '0.12', 'groupId': 'OG008'}, {'value': '5.07', 'spread': '0.19', 'groupId': 'OG009'}]}]}, {'title': 'Day 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5.01', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '5.05', 'spread': '0.14', 'groupId': 'OG001'}, {'value': '4.93', 'spread': '0.14', 'groupId': 'OG002'}, {'value': '5.06', 'spread': '0.17', 'groupId': 'OG003'}, {'value': '4.90', 'spread': '0.13', 'groupId': 'OG004'}, {'value': '4.92', 'spread': '0.15', 'groupId': 'OG005'}, {'value': '5.00', 'spread': '0.11', 'groupId': 'OG006'}, {'value': '5.23', 'spread': '0.13', 'groupId': 'OG007'}, {'value': '5.20', 'spread': '0.13', 'groupId': 'OG008'}, {'value': '5.10', 'spread': '0.20', 'groupId': 'OG009'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5.05', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '5.10', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '4.92', 'spread': '0.12', 'groupId': 'OG002'}, {'value': '5.02', 'spread': '0.16', 'groupId': 'OG003'}, {'value': '4.83', 'spread': '0.12', 'groupId': 'OG004'}, {'value': '4.98', 'spread': '0.19', 'groupId': 'OG005'}, {'value': '5.00', 'spread': '0.06', 'groupId': 'OG006'}, {'value': '5.20', 'spread': '0.22', 'groupId': 'OG007'}, {'value': '5.25', 'spread': '0.12', 'groupId': 'OG008'}, {'value': '5.07', 'spread': '0.12', 'groupId': 'OG009'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5.03', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '5.05', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '4.82', 'spread': '0.12', 'groupId': 'OG002'}, {'value': '4.92', 'spread': '0.16', 'groupId': 'OG003'}, {'value': '4.85', 'spread': '0.08', 'groupId': 'OG004'}, {'value': '5.08', 'spread': '0.17', 'groupId': 'OG005'}, {'value': '5.05', 'spread': '0.08', 'groupId': 'OG006'}, {'value': '5.18', 'spread': '0.24', 'groupId': 'OG007'}, {'value': '5.12', 'spread': '0.15', 'groupId': 'OG008'}, {'value': '5.05', 'spread': '0.21', 'groupId': 'OG009'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5.13', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '5.05', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '4.92', 'spread': '0.17', 'groupId': 'OG002'}, {'value': '5.02', 'spread': '0.20', 'groupId': 'OG003'}, {'value': '4.85', 'spread': '0.08', 'groupId': 'OG004'}, {'value': '5.22', 'spread': '0.12', 'groupId': 'OG005'}, {'value': '5.03', 'spread': '0.16', 'groupId': 'OG006'}, {'value': '5.28', 'spread': '0.17', 'groupId': 'OG007'}, {'value': '5.22', 'spread': '0.10', 'groupId': 'OG008'}, {'value': '5.13', 'spread': '0.20', 'groupId': 'OG009'}]}]}, {'title': 'Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5.16', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '4.96', 'spread': '0.14', 'groupId': 'OG003'}, {'value': '5.07', 'spread': '0.16', 'groupId': 'OG004'}, {'value': '5.11', 'spread': '0.18', 'groupId': 'OG005'}, {'value': '4.96', 'spread': '0.16', 'groupId': 'OG006'}, {'value': '5.28', 'spread': '0.13', 'groupId': 'OG007'}, {'value': '5.18', 'spread': '0.10', 'groupId': 'OG008'}, {'value': '5.18', 'spread': '0.15', 'groupId': 'OG009'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5.18', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '4.99', 'spread': '0.15', 'groupId': 'OG003'}, {'value': '5.22', 'spread': '0.13', 'groupId': 'OG004'}, {'value': '5.26', 'spread': '0.21', 'groupId': 'OG005'}, {'value': '5.02', 'spread': '0.08', 'groupId': 'OG006'}, {'value': '5.23', 'spread': '0.17', 'groupId': 'OG007'}, {'value': '5.30', 'spread': '0.13', 'groupId': 'OG008'}, {'value': '5.18', 'spread': '0.12', 'groupId': 'OG009'}]}]}, {'title': 'Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5.21', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '5.19', 'spread': '0.16', 'groupId': 'OG003'}, {'value': '5.20', 'spread': '0.11', 'groupId': 'OG004'}, {'value': '5.16', 'spread': '0.11', 'groupId': 'OG005'}, {'value': '5.00', 'spread': '0.13', 'groupId': 'OG006'}, {'value': '5.28', 'spread': '0.15', 'groupId': 'OG007'}, {'value': '5.32', 'spread': '0.13', 'groupId': 'OG008'}, {'value': '5.15', 'spread': '0.14', 'groupId': 'OG009'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5.26', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '5.22', 'spread': '0.14', 'groupId': 'OG003'}, {'value': '5.22', 'spread': '0.10', 'groupId': 'OG004'}, {'value': '5.21', 'spread': '0.15', 'groupId': 'OG005'}, {'value': '5.18', 'spread': '0.13', 'groupId': 'OG006'}, {'value': '5.33', 'spread': '0.17', 'groupId': 'OG007'}, {'value': '5.23', 'spread': '0.08', 'groupId': 'OG008'}, {'value': '5.25', 'spread': '0.15', 'groupId': 'OG009'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5.18', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '5.22', 'spread': '0.18', 'groupId': 'OG005'}, {'value': '5.13', 'spread': '0.14', 'groupId': 'OG006'}, {'value': '5.15', 'spread': '0.07', 'groupId': 'OG007'}, {'value': '5.17', 'spread': '0.14', 'groupId': 'OG009'}]}]}, {'title': 'Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5.18', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '5.38', 'spread': '0.16', 'groupId': 'OG005'}, {'value': '5.12', 'spread': '0.18', 'groupId': 'OG006'}, {'value': '5.30', 'spread': '0.28', 'groupId': 'OG007'}, {'value': '5.20', 'spread': '0.13', 'groupId': 'OG009'}]}]}, {'title': 'Day 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5.28', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '5.30', 'spread': '0.17', 'groupId': 'OG005'}, {'value': '5.15', 'spread': '0.19', 'groupId': 'OG006'}, {'value': '5.15', 'spread': '0.07', 'groupId': 'OG007'}, {'value': '5.27', 'spread': '0.15', 'groupId': 'OG009'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'categories': [{'measurements': [{'value': '5.24', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '5.36', 'spread': '0.13', 'groupId': 'OG005'}, {'value': '5.13', 'spread': '0.22', 'groupId': 'OG006'}, {'value': '5.20', 'spread': '0.14', 'groupId': 'OG007'}, {'value': '5.23', 'spread': '0.14', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 predose and at 4, 6, 8, 10, 12 hours, days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants; only participants who received ≥ 1 mg/kg romosozumab/placebo were assessed after day 29 and only participants who received 5 or 10 mg/kg romosozumab/placebo were assessed after day 57.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo SC', 'description': 'Participants received a single subcutaneous (SC) injection of matching placebo.'}, {'id': 'FG001', 'title': 'Romosozumab 0.1 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.'}, {'id': 'FG002', 'title': 'Romosozumab 0.3 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.'}, {'id': 'FG003', 'title': 'Romosozumab 1.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.'}, {'id': 'FG004', 'title': 'Romosozumab 3.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.'}, {'id': 'FG005', 'title': 'Romosozumab 5.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.'}, {'id': 'FG006', 'title': 'Romosozumab 10.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.'}, {'id': 'FG007', 'title': 'Placebo IV', 'description': 'Participants received a single intravenous (IV) injection of matching placebo.'}, {'id': 'FG008', 'title': 'Romosozumab 1.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 1.0 mg/kg romosozumab.'}, {'id': 'FG009', 'title': 'Romosozumab 5.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 5.0 mg/kg romosozumab'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}]}, {'type': 'Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was a single-center study conducted in the USA. The first participant enrolled on 13 December 2006 and the last participant completed the study on 06 July 2007.', 'preAssignmentDetails': 'Participants were enrolled sequentially into 1 of 6 dose cohorts. Healthy postmenopausal women were randomized to romosozumab or placebo in a 3:1 ratio at 0.1, 0.3, 1 mg/kg SC, 1 mg/kg IV, 3, 5 mg/kg SC, 10 mg/kg SC, or 10 mg/kg IV; healthy men received romosozumab SC or IV, placebo SC or IV in a 3:3:1:1 ratio at doses of 1 mg/kg or 10 mg/kg.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '72', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo SC', 'description': 'Participants received a single subcutaneous (SC) injection of matching placebo.'}, {'id': 'BG001', 'title': 'Romosozumab 0.1 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.1 mg/kg romosozumab.'}, {'id': 'BG002', 'title': 'Romosozumab 0.3 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 0.3 mg/kg romosozumab.'}, {'id': 'BG003', 'title': 'Romosozumab 1.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 1.0 mg/kg romosozumab.'}, {'id': 'BG004', 'title': 'Romosozumab 3.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 3.0 mg/kg romosozumab.'}, {'id': 'BG005', 'title': 'Romosozumab 5.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 5.0 mg/kg romosozumab.'}, {'id': 'BG006', 'title': 'Romosozumab 10.0 mg/kg SC', 'description': 'Participants received a single subcutaneous injection of 10.0 mg/kg romosozumab.'}, {'id': 'BG007', 'title': 'Placebo IV', 'description': 'Participants received a single intravenous (IV) injection of matching placebo.'}, {'id': 'BG008', 'title': 'Romosozumab 1.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 1.0 mg/kg romosozumab.'}, {'id': 'BG009', 'title': 'Romosozumab 5.0 mg/kg IV', 'description': 'Participants received a single intravenous injection of 5.0 mg/kg romosozumab'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'SC Dosing', 'categories': [{'measurements': [{'value': '52.79', 'spread': '4.17', 'groupId': 'BG000'}, {'value': '53.00', 'spread': '3.95', 'groupId': 'BG001'}, {'value': '53.33', 'spread': '3.20', 'groupId': 'BG002'}, {'value': '52.00', 'spread': '4.64', 'groupId': 'BG003'}, {'value': '55.00', 'spread': '4.05', 'groupId': 'BG004'}, {'value': '51.89', 'spread': '2.32', 'groupId': 'BG005'}, {'value': '52.50', 'spread': '4.32', 'groupId': 'BG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'SC dosing cohorts are reported in this row', 'groupId': 'BG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'SC dosing cohorts are reported in this row', 'groupId': 'BG008'}, {'value': 'NA', 'spread': 'NA', 'comment': 'SC dosing cohorts are reported in this row', 'groupId': 'BG009'}, {'value': '52.80', 'spread': '3.79', 'groupId': 'BG010'}]}]}, {'title': 'IV Dosing', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'IV dosing cohorts are reported in this row', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'IV dosing cohorts are reported in this row', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'IV dosing cohorts are reported in this row', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'IV dosing cohorts are reported in this row', 'groupId': 'BG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'IV dosing cohorts are reported in this row', 'groupId': 'BG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'IV dosing cohorts are reported in this row', 'groupId': 'BG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'IV dosing cohorts are reported in this row', 'groupId': 'BG006'}, {'value': '52.50', 'spread': '4.43', 'groupId': 'BG007'}, {'value': '49.33', 'spread': '4.63', 'groupId': 'BG008'}, {'value': '51.00', 'spread': '3.35', 'groupId': 'BG009'}, {'value': '50.75', 'spread': '4.06', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '56', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '16', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White or Caucasian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}]}, {'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '65', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All treated participants'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2007-07-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-03', 'studyFirstSubmitDate': '2010-01-28', 'resultsFirstSubmitDate': '2019-04-10', 'studyFirstSubmitQcDate': '2010-01-29', 'lastUpdatePostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-03', 'studyFirstPostDateStruct': {'date': '2010-02-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-07-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Adverse events were collected from the first dose of treatment up until day 29 for the 0.1 mg/kg and 0.3 mg/kg SC treatment groups, up to 57 days for the 1 mg/kg and 3 mg/kg IV/SC groups and for up to 85 days for the 5 mg/kg and 10 mg/kg SC/IV groups.', 'description': 'Serious adverse events were any events that were fatal, were life-threatening (placed the participant at immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, were congenital anomalies or birth defects, or were other significant medical hazards.\n\nRelatedness to investigational product was assessed by the investigator by means of the question: "Is there a reasonable possibility that the event may have been caused by the investigational product?\''}, {'measure': 'Number of Participants Who Developed Anti-romosozumab Antibodies', 'timeFrame': 'Day 29 (all participants), day 57 (1, 3, 5, and 10 mg/kg treatment groups only) and at day 85 (5 and 10 mg/kg teatment groups only).', 'description': 'Binding anti-romosozumab antibody titers were assessed using a validated electrochemiluninescence (ECL) immunoassay. The limit of detection for this assay was 3.91 ng/mL of anti-romosozumab antibody in neat serum. Samples found to be positive for binding antibodies were further tested using a validated bioassay to determine if the antibodies were able to neutralize the activity of romosozumab. The limit of detection for this assay was ≥ 0.75 μg/mL.'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Concentration (Cmax) of Romosozumab', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.'}, {'measure': 'Time to Maximum Observed Concentration (Tmax) of Romosozumab', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.'}, {'measure': 'Initial Concentration Following IV Administration (C0) of Romosozumab', 'timeFrame': 'Day 1 at the end of infusion'}, {'measure': 'Area Under the Serum Concentration-time Curve From Time Zero to Infinity for Romosozumab', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.'}, {'measure': 'Apparent Clearance (CL/F) / Clearance (CL) for Romosozumab', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.'}, {'measure': 'Half-life Associated With the Beta (Plateau) Phase of Elimination for Romosozumab', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'description': 'The plateau (beta, β) phase half-life (t½,β) was calculated from the natural log of 2 divided by the beta phase rate constant (λβ). λβ for a subject was estimated by linear regression of at least 3 contiguous time points that followed the Cmax and constituted a distinct phase that preceded the terminal phase.'}, {'measure': 'Half-life Associated With the Gamma (Terminal) Phase of Elimination for Romosozumab', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'description': 'The terminal (gamma, γ) phase half-life (t½,γ) was calculated from the natural log of 2 divided by the terminal rate constant (λz).'}, {'measure': 'Maximum Effect for Serum Type 1 Aminoterminal Propeptide (P1NP)', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'description': 'Defined as the maximum value postdose.'}, {'measure': 'Time to Maximum Effect of P1NP', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'description': 'Defined as the time to maximum value postdose.'}, {'measure': 'Area Under the Curve From Day 0 to Day 29 (AUC0-29) for P1NP', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.'}, {'measure': 'Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for P1NP', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab,'}, {'measure': 'Maximum Effect for Serum C-telopeptide (sCTX)', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'description': 'Defined as the minimum value postdose.'}, {'measure': 'Time to Maximum Effect of sCTX', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'description': 'Defined as the time to minimum value postdose.'}, {'measure': 'Area Under the Curve From Day 0 to Day 29 (AUC0-29) for sCTX', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.'}, {'measure': 'Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for sCTX', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.'}, {'measure': 'Maximum Effect for Osteocalcin', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'description': 'Defined as the maximum value postdose.'}, {'measure': 'Time to Maximum Effect of Osteocalcin', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'description': 'Defined as the time to maximum value postdose.'}, {'measure': 'Area Under the Curve From Day 0 to Day 29 (AUC0-29) for Osteocalcin', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.'}, {'measure': 'Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for Osteocalcin', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.'}, {'measure': 'Maximum Effect for Bone-specific Alkaline Phosphatase (BSAP)', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'description': 'Defined as the maximum value postdose.'}, {'measure': 'Time to Maximum Effect of BSAP', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'description': 'Defined as the time to maximum value postdose.'}, {'measure': 'Area Under the Curve From Day 0 to Day 29 (AUC0-29) for BSAP', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.'}, {'measure': 'Area Under the Curve From Day 0 to the Last Sampling Time Point (AUC0-t) for BSAP', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.'}, {'measure': 'Maximum Effect for Intact Parathyroid Hormone (iPTH)', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'description': 'Defined as the maximum value postdose.'}, {'measure': 'Time to Maximum Effect of iPTH', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.', 'description': 'Defined as the time to maximum value postdose.'}, {'measure': 'Area Under the Curve From Day 0 to Day 29 (AUC0-29) for iPTH', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.'}, {'measure': 'Area Under the Curve From Day 0 to the Last Sampling Timepoint (AUC0-t) for iPTH', 'timeFrame': 'Predose up to day 29 for participants receiving 0.1 or 0.3 mg/kg romosozumab, up to day 57 for participants receiving 1 or 3 mg/kg romosozumab, and up to day 85 for participants receiving 5 or 10 mg/kg romosozumab.'}, {'measure': 'Percent Change From Baseline in Sclerostin', 'timeFrame': 'Baseline and days 15, 29, 43, 57, 71, and 85'}, {'measure': 'Serum Calcium Over Time', 'timeFrame': 'Dday 1 predose and at 4, 6, 8, 10, and 12 hours, days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85'}, {'measure': 'Ionized Calcium Over Time', 'timeFrame': 'Day 1 predose and at 4, 6, 8, 10, 12 hours, days 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85'}]}, 'conditionsModule': {'keywords': ['Amgen', 'First in Human', 'Postmenopausal', 'Phase 1'], 'conditions': ['Osteopenia']}, 'referencesModule': {'references': [{'pmid': '20593411', 'type': 'BACKGROUND', 'citation': 'Padhi D, Jang G, Stouch B, Fang L, Posvar E. Single-dose, placebo-controlled, randomized study of AMG 785, a sclerostin monoclonal antibody. J Bone Miner Res. 2011 Jan;26(1):19-26. doi: 10.1002/jbmr.173.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the safety and tolerability of romosozumab following single dose subcutaneous (SC) or intravenous (IV) administration in healthy men and postmenopausal women.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy males or female between 45 to 59 years of age, inclusive\n* Postmenopausal females defined as 12 continuous months of spontaneous amenorrhea confirmed by a serum follicle-stimulating hormone (FSH) result \\> 40mIU/mL, or 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy)\n* Males must agree to use a condom during sexual intercourse with female partners who are of reproductive potential and to have their female partners use an additional effective means of contraception or to abstain from sexual intercourse for the duration of the study\n* Has no history or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion\n\nExclusion Criteria:\n\n* Diagnosed with any condition that will affect bone metabolism\n* Administration of the following medications within 6 months before study drug administration:\n* Hormone replacement therapy \\[Infrequent use of estrogen vaginal creams (\\< 3 times per week) is allowed.\\]\n* Calcitonin\n* Parathyroid hormone (or any derivative)\n* Supplemental Vitamin D \\> 1,000 IU/day\n* Glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the enrollment date are allowed)\n* Anabolic steroids\n* Calcitriol, and available analogues\n* Administration of the following medications within 12 months before study drug administration:\n* Bisphosphonates\n* Fluoride for osteoporosis\n* Administration of herbal medications within 2 weeks or 5 half-lives (whichever is longer) before study drug administration\n* Greatly differing levels of physical activity or constant levels of intense physical exercise during the 6 months before study drug administration\n* Routine alcohol intake of \\> 2 drinks per day, on average, within 6 months of study drug administration\n* Known sensitivity to mammalian-derived drug preparations\n* Known to be hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus (HIV) positive, or a known diagnosis of acquired immunodeficiency syndrome (AIDS)\n* Any organic or psychiatric disorder which may pose a risk to subject safety and may prevent the subject from completing the study or interfere with the interpretation of the study results\n* Unavailable for follow-up assessment or any concerns for subject's compliance with the protocol procedures\n* Any other condition that might reduce the chance of obtaining data required by the protocol or that might compromise the ability to give truly informed consent\n* Has a history of drug or alcohol abuse with the last 12 months and/or a positive urine test result at screening or admission\n* Has any clinically significant abnormality during the screening physical examination, electrocardiogram (ECG), or laboratory evaluation\n* Has participated in another clinical study within 4 weeks of screening or within 5 times the half-life of the investigational agent in the other clinical study, if known\n* Weight ≥ 98 kilograms (216 pounds) and/or height ≥ 78 inches\n* Has donated or lost 400 milliliters or more of blood or plasma within 8 weeks of study drug administration"}, 'identificationModule': {'nctId': 'NCT01059435', 'briefTitle': 'A First-in-human Study Evaluating Romosozumab (AMG 785) in Healthy Men and Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Ascending Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 785 in Healthy Men and Postmenopausal Women', 'orgStudyIdInfo': {'id': '20060220'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants were randomized to receive a single dose of matching placebo administered by subcutaneous or intravenous injection.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Romosozumab', 'description': 'Participants were randomized to receive a single dose of romosozumab administered by subcutaneous or intravenous injection. The starting dose was 0.1 mg/kg, with sequential escalation up to 10 mg/kg.', 'interventionNames': ['Drug: Romosozumab']}], 'interventions': [{'name': 'Romosozumab', 'type': 'DRUG', 'otherNames': ['AMG 785', 'EVENITY™'], 'description': 'Administered subcutaneously or intravenously', 'armGroupLabels': ['Romosozumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered subcutaneously or intravenously', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}