Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-29 @ 12:44 AM
Study NCT ID:
NCT01101061
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2010-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments', 'description': 'Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.', 'eventGroups': [{'id': 'EG000', 'title': 'Japanese Women: Placebo', 'description': 'Japanese participants received a single subcutaneous injection of placebo on day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Japanese Women: Romosozumab 1 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Japanese Women: Romosozumab 3 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Japanese Women: Romosozumab 5 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Non-Japanese Women: Placebo', 'description': 'Non-Japanese participants received a single subcutaneous injection of placebo on day 1.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Non-Japanese Women: Romosozumab 3 mg/kg', 'description': 'Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vessel puncture site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vessel puncture site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Herpes virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Post procedural swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Venomous sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Muscle twitching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Eye 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': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Japanese Women: Placebo', 'description': 'Japanese participants received a single subcutaneous injection of placebo on day 1.'}, {'id': 'OG001', 'title': 'Japanese Women: Romosozumab 1 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.'}, {'id': 'OG002', 'title': 'Japanese Women: Romosozumab 3 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.'}, {'id': 'OG003', 'title': 'Japanese Women: Romosozumab 5 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.'}, {'id': 'OG004', 'title': 'Non-Japanese Women: Placebo', 'description': 'Non-Japanese participants received a single subcutaneous injection of placebo on day 1.'}, {'id': 'OG005', 'title': 'Non-Japanese Women: Romosozumab 3 mg/kg', 'description': 'Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'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'}]}]}, {'title': 'Treatment-related adverse events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'AEs leading to discontinuation of study drug', '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'}]}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments.', 'description': 'A serious adverse event (SAE) is defined as an adverse event that\n\n* is fatal\n* is life threatening\n* requires in-patient hospitalization or prolongation of existing hospitalization\n* results in persistent or significant disability/incapacity\n* is a congenital anomaly/birth defect\n* other significant medical hazard. A treatment-related AE is any treatment-emergent AE that per investigator review has a reasonable possibility of being caused by the investigational product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Developed Anti-romosozumab Binding Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Japanese Women: Placebo', 'description': 'Japanese participants received a single subcutaneous injection of placebo on day 1.'}, {'id': 'OG001', 'title': 'Japanese Women: Romosozumab 1 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.'}, {'id': 'OG002', 'title': 'Japanese Women: Romosozumab 3 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.'}, {'id': 'OG003', 'title': 'Japanese Women: Romosozumab 5 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.'}, {'id': 'OG004', 'title': 'Non-Japanese Women: Placebo', 'description': 'Non-Japanese participants received a single subcutaneous injection of placebo on day 1.'}, {'id': 'OG005', 'title': 'Non-Japanese Women: Romosozumab 3 mg/kg', 'description': 'Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.'}], 'classes': [{'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 29, and end of study (day 57 for participants assigned to 1 or 3 mg/kg romosozumab/placebo or day 85 for participants assigned to 5 mg/kg romosozumab/placebo)', 'description': 'Participants who were negative for anti-romosozumab binding antibodies at baseline with a positive result at any time post-baseline.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'PRIMARY', 'title': 'Serum Calcium Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Japanese Women: Placebo', 'description': 'Japanese participants received a single subcutaneous injection of placebo on day 1.'}, {'id': 'OG001', 'title': 'Japanese Women: Romosozumab 1 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.'}, {'id': 'OG002', 'title': 'Japanese Women: Romosozumab 3 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.'}, {'id': 'OG003', 'title': 'Japanese Women: Romosozumab 5 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.'}, {'id': 'OG004', 'title': 'Non-Japanese Women: Placebo', 'description': 'Non-Japanese participants received a single subcutaneous injection of placebo on day 1.'}, {'id': 'OG005', 'title': 'Non-Japanese Women: Romosozumab 3 mg/kg', 'description': 'Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.34', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '2.31', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '2.33', 'spread': '0.03', 'groupId': 'OG002'}, {'value': '2.38', 'spread': '0.03', 'groupId': 'OG003'}, {'value': '2.28', 'spread': '0.08', 'groupId': 'OG004'}, {'value': '2.45', 'spread': '0.04', 'groupId': 'OG005'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.33', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '2.34', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '2.31', 'spread': '0.03', 'groupId': 'OG002'}, {'value': '2.36', 'spread': '0.03', 'groupId': 'OG003'}, {'value': '2.34', 'spread': '0.04', 'groupId': 'OG004'}, {'value': '2.40', 'spread': '0.05', 'groupId': 'OG005'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.33', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '2.36', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '2.31', 'spread': '0.03', 'groupId': 'OG002'}, {'value': '2.38', 'spread': '0.03', 'groupId': 'OG003'}, {'value': '2.34', 'spread': '0.01', 'groupId': 'OG004'}, {'value': '2.43', 'spread': '0.03', 'groupId': 'OG005'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.32', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '2.31', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '2.30', 'spread': '0.03', 'groupId': 'OG002'}, {'value': '2.32', 'spread': '0.03', 'groupId': 'OG003'}, {'value': '2.38', 'spread': '0.02', 'groupId': 'OG004'}, {'value': '2.36', 'spread': '0.04', 'groupId': 'OG005'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.39', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '2.30', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '2.31', 'spread': '0.04', 'groupId': 'OG002'}, {'value': '2.35', 'spread': '0.04', 'groupId': 'OG003'}, {'value': '2.28', 'spread': '0.02', 'groupId': 'OG004'}, {'value': '2.40', 'spread': '0.03', 'groupId': 'OG005'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.39', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '2.25', 'spread': '0.02', 'groupId': 'OG001'}, {'value': '2.31', 'spread': '0.03', 'groupId': 'OG002'}, {'value': '2.29', 'spread': '0.03', 'groupId': 'OG003'}, {'value': '2.35', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '2.38', 'spread': '0.03', 'groupId': 'OG005'}]}]}, {'title': 'Day 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.35', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '2.27', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '2.33', 'spread': '0.03', 'groupId': 'OG002'}, {'value': '2.28', 'spread': '0.02', 'groupId': 'OG003'}, {'value': '2.33', 'spread': '0.03', 'groupId': 'OG004'}, {'value': '2.28', 'spread': '0.04', 'groupId': 'OG005'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.31', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '2.31', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '2.28', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '2.25', 'spread': '0.03', 'groupId': 'OG003'}, {'value': '2.33', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '2.36', 'spread': '0.03', 'groupId': 'OG005'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.37', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '2.30', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '2.28', 'spread': '0.03', 'groupId': 'OG002'}, {'value': '2.30', 'spread': '0.02', 'groupId': 'OG003'}, {'value': '2.36', 'spread': '0.04', 'groupId': 'OG004'}, {'value': '2.38', 'spread': '0.05', 'groupId': 'OG005'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.35', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '2.33', 'spread': '0.03', 'groupId': 'OG001'}, {'value': '2.28', 'spread': '0.03', 'groupId': 'OG002'}, {'value': '2.34', 'spread': '0.04', 'groupId': 'OG003'}, {'value': '2.30', 'spread': '0.07', 'groupId': 'OG004'}, {'value': '2.34', 'spread': '0.01', 'groupId': 'OG005'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.37', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '2.32', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '2.29', 'spread': '0.04', 'groupId': 'OG002'}, {'value': '2.30', 'spread': '0.03', 'groupId': 'OG003'}, {'value': '2.28', 'spread': '0.00', 'groupId': 'OG004'}, {'value': '2.31', 'spread': '0.02', 'groupId': 'OG005'}]}]}, {'title': 'Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.34', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '2.39', 'spread': '0.02', 'groupId': 'OG003'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.29', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '2.35', 'spread': '0.02', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants; only participants in the 5 mg/kg cohort were assessed at days 71 and 85.'}, {'type': 'PRIMARY', 'title': 'Serum Intact Parathyroid Hormone (iPTH) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Japanese Women: Placebo', 'description': 'Japanese participants received a single subcutaneous injection of placebo on day 1.'}, {'id': 'OG001', 'title': 'Japanese Women: Romosozumab 1 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.'}, {'id': 'OG002', 'title': 'Japanese Women: Romosozumab 3 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.'}, {'id': 'OG003', 'title': 'Japanese Women: Romosozumab 5 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.'}, {'id': 'OG004', 'title': 'Non-Japanese Women: Placebo', 'description': 'Non-Japanese participants received a single subcutaneous injection of placebo on day 1.'}, {'id': 'OG005', 'title': 'Non-Japanese Women: Romosozumab 3 mg/kg', 'description': 'Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.47', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '4.24', 'spread': '0.70', 'groupId': 'OG001'}, {'value': '4.93', 'spread': '0.84', 'groupId': 'OG002'}, {'value': '3.63', 'spread': '0.62', 'groupId': 'OG003'}, {'value': '3.77', 'spread': '1.65', 'groupId': 'OG004'}, {'value': '2.73', 'spread': '0.37', 'groupId': 'OG005'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.51', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '4.92', 'spread': '0.78', 'groupId': 'OG001'}, {'value': '5.01', 'spread': '0.47', 'groupId': 'OG002'}, {'value': '4.23', 'spread': '0.54', 'groupId': 'OG003'}, {'value': '3.50', 'spread': '1.49', 'groupId': 'OG004'}, {'value': '2.57', 'spread': '0.23', 'groupId': 'OG005'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.93', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '4.69', 'spread': '0.69', 'groupId': 'OG001'}, {'value': '5.38', 'spread': '0.44', 'groupId': 'OG002'}, {'value': '4.58', 'spread': '0.76', 'groupId': 'OG003'}, {'value': '3.50', 'spread': '1.06', 'groupId': 'OG004'}, {'value': '2.89', 'spread': '0.37', 'groupId': 'OG005'}]}]}, {'title': 'Day 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.47', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '5.09', 'spread': '0.69', 'groupId': 'OG001'}, {'value': '5.09', 'spread': '0.23', 'groupId': 'OG002'}, {'value': '5.20', 'spread': '1.13', 'groupId': 'OG003'}, {'value': '3.93', 'spread': '1.70', 'groupId': 'OG004'}, {'value': '3.55', 'spread': '0.73', 'groupId': 'OG005'}]}]}, {'title': 'Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.21', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '4.97', 'spread': '0.93', 'groupId': 'OG001'}, {'value': '5.75', 'spread': '0.72', 'groupId': 'OG002'}, {'value': '4.44', 'spread': '0.77', 'groupId': 'OG003'}, {'value': '3.82', 'spread': '1.49', 'groupId': 'OG004'}, {'value': '3.66', 'spread': '0.66', 'groupId': 'OG005'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.19', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '5.91', 'spread': '0.86', 'groupId': 'OG001'}, {'value': '5.23', 'spread': '0.68', 'groupId': 'OG002'}, {'value': '4.79', 'spread': '0.90', 'groupId': 'OG003'}, {'value': '4.14', 'spread': '1.91', 'groupId': 'OG004'}, {'value': '3.98', 'spread': '0.68', 'groupId': 'OG005'}]}]}, {'title': 'Day 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5.04', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '6.42', 'spread': '0.59', 'groupId': 'OG001'}, {'value': '5.46', 'spread': '0.41', 'groupId': 'OG002'}, {'value': '5.80', 'spread': '0.61', 'groupId': 'OG003'}, {'value': '4.19', 'spread': '1.86', 'groupId': 'OG004'}, {'value': '4.46', 'spread': '0.64', 'groupId': 'OG005'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.69', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '5.57', 'spread': '0.64', 'groupId': 'OG001'}, {'value': '6.15', 'spread': '0.56', 'groupId': 'OG002'}, {'value': '7.09', 'spread': '0.84', 'groupId': 'OG003'}, {'value': '5.46', 'spread': '2.71', 'groupId': 'OG004'}, {'value': '4.62', 'spread': '0.68', 'groupId': 'OG005'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.83', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '5.02', 'spread': '0.74', 'groupId': 'OG001'}, {'value': '5.92', 'spread': '0.68', 'groupId': 'OG002'}, {'value': '6.14', 'spread': '0.72', 'groupId': 'OG003'}, {'value': '4.83', 'spread': '2.81', 'groupId': 'OG004'}, {'value': '4.43', 'spread': '0.40', 'groupId': 'OG005'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.61', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '6.03', 'spread': '0.73', 'groupId': 'OG001'}, {'value': '5.27', 'spread': '0.32', 'groupId': 'OG002'}, {'value': '5.61', 'spread': '0.84', 'groupId': 'OG003'}, {'value': '3.93', 'spread': '1.27', 'groupId': 'OG004'}, {'value': '3.53', 'spread': '0.35', 'groupId': 'OG005'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.89', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '4.90', 'spread': '0.64', 'groupId': 'OG001'}, {'value': '4.87', 'spread': '0.39', 'groupId': 'OG002'}, {'value': '4.86', 'spread': '0.55', 'groupId': 'OG003'}, {'value': '2.76', 'spread': '0.85', 'groupId': 'OG004'}, {'value': '2.68', 'spread': '0.27', 'groupId': 'OG005'}]}]}, {'title': 'Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.40', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '4.10', 'spread': '0.47', 'groupId': 'OG003'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.02', 'spread': '0.80', 'groupId': 'OG000'}, 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The lower limit of quantification (LLOQ) was 50 ng/mL.', 'unitOfMeasure': 'mL/day/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants who received romosozumab'}, {'type': 'SECONDARY', 'title': 'Half-life Associated With Beta (Plateau) Phase of Elimination (T1/2,β) for Romosozumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Japanese Women: Romosozumab 1 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.'}, {'id': 'OG001', 'title': 'Japanese Women: Romosozumab 3 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.'}, {'id': 'OG002', 'title': 'Japanese Women: Romosozumab 5 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.'}, {'id': 'OG003', 'title': 'Non-Japanese Women: Romosozumab 3 mg/kg', 'description': 'Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.1', 'spread': 'NA', 'comment': 'Could not be calculated for 1 participant', 'groupId': 'OG001'}, {'value': '16.2', 'spread': '4.1', 'groupId': 'OG002'}, {'value': '15.3', 'spread': '6.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.', 'description': 'Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants who received romosozumab with available T1/2,β data'}, {'type': 'SECONDARY', 'title': 'Half-life Associated With Gamma (Terminal) Phase of Elimination (T1/2,ɣ) for Romosozumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Japanese Women: Romosozumab 1 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.'}, {'id': 'OG001', 'title': 'Japanese Women: Romosozumab 3 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.'}, {'id': 'OG002', 'title': 'Japanese Women: Romosozumab 5 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.'}, {'id': 'OG003', 'title': 'Non-Japanese Women: Romosozumab 3 mg/kg', 'description': 'Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.82', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '6.31', 'spread': '1.14', 'groupId': 'OG001'}, {'value': '7.19', 'spread': '1.55', 'groupId': 'OG002'}, {'value': '6.81', 'spread': '2.69', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.', 'description': 'Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants who received romosozumab'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Japanese Women: Placebo', 'description': 'Japanese participants received a single subcutaneous injection of placebo on day 1.'}, {'id': 'FG001', 'title': 'Japanese Women: Romosozumab 1 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.'}, {'id': 'FG002', 'title': 'Japanese Women: Romosozumab 3 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.'}, {'id': 'FG003', 'title': 'Japanese Women: Romosozumab 5 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.'}, {'id': 'FG004', 'title': 'Non-Japanese Women: Placebo', 'description': 'Non-Japanese participants received a single subcutaneous injection of placebo on day 1.'}, {'id': 'FG005', 'title': 'Non-Japanese Women: Romosozumab 3 mg/kg', 'description': 'Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at 2 study centers in the United States. Eligible participants were healthy, postmenopausal first, second, or third generation Japanese women and non-Japanese women residing in the United States.', 'preAssignmentDetails': 'Participants were assigned to one of 4 cohorts. In 3 of the cohorts Japanese women were randomized in a 3:1 ratio to receive 1, 3, or 5 mg/kg romosozumab or placebo. In a 4th cohort non-Japanese women were randomized in a 2:1 ratio to receive 3 mg/kg romosozumab or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Japanese Women: Placebo', 'description': 'Japanese participants received a single subcutaneous injection of placebo on day 1.'}, {'id': 'BG001', 'title': 'Japanese Women: Romosozumab 1 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 1 mg/kg romosozumab on day 1.'}, {'id': 'BG002', 'title': 'Japanese Women: Romosozumab 3 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.'}, {'id': 'BG003', 'title': 'Japanese Women: Romosozumab 5 mg/kg', 'description': 'Japanese participants received a single subcutaneous injection of 5 mg/kg romosozumab on day 1.'}, {'id': 'BG004', 'title': 'Non-Japanese Women: Placebo', 'description': 'Non-Japanese participants received a single subcutaneous injection of placebo on day 1.'}, {'id': 'BG005', 'title': 'Non-Japanese Women: Romosozumab 3 mg/kg', 'description': 'Non-Japanese participants received a single subcutaneous injection of 3 mg/kg romosozumab on day 1.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.8', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '59.3', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '61.7', 'spread': '3.0', 'groupId': 'BG002'}, {'value': '59.7', 'spread': '7.7', 'groupId': 'BG003'}, {'value': '57.5', 'spread': '3.5', 'groupId': 'BG004'}, {'value': '55.0', 'spread': '4.8', 'groupId': 'BG005'}, {'value': '59.5', 'spread': '5.3', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}]}, {'title': 'Male', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '25', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}]}], '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': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2010-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-29', 'studyFirstSubmitDate': '2010-04-08', 'resultsFirstSubmitDate': '2019-04-10', 'studyFirstSubmitQcDate': '2010-04-08', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-29', 'studyFirstPostDateStruct': {'date': '2010-04-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments.', 'description': 'A serious adverse event (SAE) is defined as an adverse event that\n\n* is fatal\n* is life threatening\n* requires in-patient hospitalization or prolongation of existing hospitalization\n* results in persistent or significant disability/incapacity\n* is a congenital anomaly/birth defect\n* other significant medical hazard. A treatment-related AE is any treatment-emergent AE that per investigator review has a reasonable possibility of being caused by the investigational product.'}, {'measure': 'Number of Participants Who Developed Anti-romosozumab Binding Antibodies', 'timeFrame': 'Day 29, and end of study (day 57 for participants assigned to 1 or 3 mg/kg romosozumab/placebo or day 85 for participants assigned to 5 mg/kg romosozumab/placebo)', 'description': 'Participants who were negative for anti-romosozumab binding antibodies at baseline with a positive result at any time post-baseline.'}, {'measure': 'Serum Calcium Levels', 'timeFrame': 'Baseline, days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85'}, {'measure': 'Serum Intact Parathyroid Hormone (iPTH) Levels', 'timeFrame': 'Baseline and days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85'}], 'secondaryOutcomes': [{'measure': 'Maximum Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)', 'timeFrame': 'Baseline and days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85'}, {'measure': 'Maximum Percent Change From Baseline in Serum C-telopeptide (CTX)', 'timeFrame': 'Baseline and days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85'}, {'measure': 'Percent Change From Baseline in Sclerostin', 'timeFrame': 'Baseline and days 12, 29, 43, 57, 71, and 85'}, {'measure': 'Time to Maximum Observed Concentration of Romosozumab', 'timeFrame': 'Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.', 'description': 'Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.'}, {'measure': 'Maximum Observed Concentration of Romosozumab', 'timeFrame': 'Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.', 'description': 'Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.'}, {'measure': 'Area Under the Serum Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Romosozumab', 'timeFrame': 'Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.', 'description': 'Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.'}, {'measure': 'Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for Romosozumab', 'timeFrame': 'Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.', 'description': 'Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.'}, {'measure': 'Apparent Clearance (CL/F) of Romosozumab', 'timeFrame': 'Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.', 'description': 'Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.'}, {'measure': 'Half-life Associated With Beta (Plateau) Phase of Elimination (T1/2,β) for Romosozumab', 'timeFrame': 'Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.', 'description': 'Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.'}, {'measure': 'Half-life Associated With Gamma (Terminal) Phase of Elimination (T1/2,ɣ) for Romosozumab', 'timeFrame': 'Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.', 'description': 'Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.'}]}, 'conditionsModule': {'keywords': ['Amgen', 'Phase 1', 'Postmenopausal', 'Japanese'], 'conditions': ['Osteopenia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to assess the safety, tolerability and potential immune response to romosozumab following single subcutaneous (SC; injection under the skin) dose administration in healthy postmenopausal Japanese and non-Japanese women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese subjects must be first (4 grandparents, biologic parents and subject born in Japan), second (4 grandparents and biological parents born in Japan) or third (4 grandparents born in Japan) generation Japanese\n* Body mass index ≤ 25 kg/m², inclusive at screening\n* Postmenopausal females defined as 12 continuous months of spontaneous amenorrhea confirmed by a serum follicle-stimulating hormone (FSH) result \\> 40 mIU/mL, or 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy) as documented in medical history (verified with an operative note, if available)\n\nExclusion Criteria:\n\n* Osteoporosis, as defined by bone mineral density (BMD) T-scores of the lumbar spine (L1-L4) or total evaluable vertebrae (if fewer than L1-L4); or femoral neck ≤ -2.5\n* History of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis;\n* Diagnosed with any condition that will affect bone metabolism'}, 'identificationModule': {'nctId': 'NCT01101061', 'briefTitle': 'A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 785 in Healthy Postmenopausal Japanese Women', 'orgStudyIdInfo': {'id': '20090378'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Romosozumab', 'description': 'Japanese women in cohorts 1, 2, and 4 will receive a single dose of 1, 3, or 5 mg/kg romosozumab. Non-Japanese women in cohort 3 will receive a single dose of 3 mg/kg romosozumab.', 'interventionNames': ['Drug: Romosozumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive a single dose of placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Romosozumab', 'type': 'DRUG', 'otherNames': ['AMG 785', 'EVENITY™'], 'description': 'Administered by subcutaneous injection', 'armGroupLabels': ['Romosozumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered by subcutaneous injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}