Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-01-04 @ 9:35 AM
Study NCT ID:
NCT00325468
Status:
COMPLETED
Last Update Posted:
2017-08-01
First Post:
2006-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D010024', 'term': 'Osteoporosis'}], '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': 'D000069448', 'term': 'Denosumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '48 months (i.e., 4 years during the 20050233 extension study)', 'description': 'The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.', 'otherNumAtRisk': 23, 'otherNumAffected': 18, 'seriousNumAtRisk': 23, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Denosumab 210 mg Q6M', 'description': 'In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.', 'otherNumAtRisk': 17, 'otherNumAffected': 15, 'seriousNumAtRisk': 17, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Denosumab 30 mg Q3M', 'description': 'In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.', 'otherNumAtRisk': 14, 'otherNumAffected': 13, 'seriousNumAtRisk': 14, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'Denosumab Continuous Treatment', 'description': 'In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.', 'otherNumAtRisk': 124, 'otherNumAffected': 106, 'seriousNumAtRisk': 124, 'seriousNumAffected': 31}, {'id': 'EG004', 'title': 'Alendronate 70 mg QW', 'otherNumAtRisk': 22, 'otherNumAffected': 19, 'seriousNumAtRisk': 22, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'All Participants', 'otherNumAtRisk': 200, 'otherNumAffected': 171, 'seriousNumAtRisk': 200, 'seriousNumAffected': 45}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ear congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 7}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 6}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Angle closure glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blepharospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 22}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Scleral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 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Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.8', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '65.8', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '68.0', 'spread': '7.2', 'groupId': 'BG002'}, {'value': '65.8', 'spread': '7.0', 'groupId': 'BG003'}, {'value': '66.6', 'spread': '8.9', 'groupId': 'BG004'}, {'value': '66.1', 'spread': '7.7', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}, {'value': '22', 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'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'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'}]}]}, {'title': 'Aborigine', 'categories': [{'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'}]}]}, {'title': 'Other', 'categories': [{'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'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Bone Mineral Density T-score of Each Anatomic Site', 'classes': [{'title': 'Lumbar spine BMD T-score', 'categories': [{'measurements': [{'value': '-2.36', 'spread': '0.62', 'groupId': 'BG000'}, {'value': '-2.02', 'spread': '1.16', 'groupId': 'BG001'}, {'value': '-1.29', 'spread': '0.94', 'groupId': 'BG002'}, {'value': '-1.35', 'spread': '0.87', 'groupId': 'BG003'}, {'value': '-1.64', 'spread': '1.09', 'groupId': 'BG004'}, {'value': '-1.55', 'spread': '0.96', 'groupId': 'BG005'}]}]}, {'title': 'Total hip BMD T-score', 'categories': [{'measurements': [{'value': '-1.63', 'spread': '0.75', 'groupId': 'BG000'}, {'value': '-1.39', 'spread': '0.67', 'groupId': 'BG001'}, {'value': '-1.05', 'spread': '0.75', 'groupId': 'BG002'}, {'value': '-1.08', 'spread': '0.68', 'groupId': 'BG003'}, {'value': '-1.50', 'spread': '0.81', 'groupId': 'BG004'}, {'value': '-1.21', 'spread': '0.73', 'groupId': 'BG005'}]}]}, {'title': 'Distal 1/3 radius T-score', 'categories': [{'measurements': [{'value': '-1.91', 'spread': '1.25', 'groupId': 'BG000'}, {'value': '-1.45', 'spread': '0.98', 'groupId': 'BG001'}, {'value': '-1.14', 'spread': '1.29', 'groupId': 'BG002'}, {'value': '-1.23', 'spread': '1.21', 'groupId': 'BG003'}, {'value': '-1.57', 'spread': '0.98', 'groupId': 'BG004'}, {'value': '-1.35', 'spread': '1.19', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': "A bone mineral density (BMD) T-score is unit-less and represents the difference, in terms of number of standard deviations, between a subject's BMD value and the average BMD value of a gender-specific young normal reference.", 'unitOfMeasure': 'T-score', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2012-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-03', 'studyFirstSubmitDate': '2006-05-10', 'resultsFirstSubmitDate': '2013-01-03', 'studyFirstSubmitQcDate': '2006-05-10', 'lastUpdatePostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-07-23', 'studyFirstPostDateStruct': {'date': '2006-05-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8', 'timeFrame': '8 years'}, {'measure': 'Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8', 'timeFrame': '8 years'}, {'measure': 'Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8', 'timeFrame': '8 years'}], 'secondaryOutcomes': [{'measure': 'Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8', 'timeFrame': '8 years'}, {'measure': 'Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8', 'timeFrame': '8 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bone loss', 'osteoporosis'], 'conditions': ['Low Bone Mineral Density']}, 'referencesModule': {'references': [{'pmid': '21159841', 'type': 'DERIVED', 'citation': 'Miller PD, Wagman RB, Peacock M, Lewiecki EM, Bolognese MA, Weinstein RL, Ding B, San Martin J, McClung MR. Effect of denosumab on bone mineral density and biochemical markers of bone turnover: six-year results of a phase 2 clinical trial. J Clin Endocrinol Metab. 2011 Feb;96(2):394-402. doi: 10.1210/jc.2010-1805. Epub 2010 Dec 15.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must be ambulatory\n* Subject must have atteneded the 20010223 end-of-study visit and have completed all tests and procedures during the end-of-study visit\n* signed informed consent must be obtained before any study-specific procedures\n\nExclusion Criteria:\n\n* Experienced severe and/or serious adverse event which were thought to be related to denosumab administration during the 20010223 study.\n* Developed grade 3 or 4 laboratory abnormalities based on Common Terminology Criteria for Adverse Events v3.0 during the 20010223 study which did not normalized upon follow up or did not have diagnosis or treatment.\n* Newly diagnosed conditions such as hyper/hypo thyroidism, rheumatoid arthritis, other bone diseases, renal disease.\n* Using therapies while participating in the 20010223 study such as oral bisphosphonates, calcitonin, oral strontium, SERMS, systemic glucocortiocosteriods.'}, 'identificationModule': {'nctId': 'NCT00325468', 'briefTitle': 'An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density', 'orgStudyIdInfo': {'id': '20050233'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMG 162', 'description': 'AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42', 'interventionNames': ['Drug: AMG 162']}], 'interventions': [{'name': 'AMG 162', 'type': 'DRUG', 'description': 'AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42', 'armGroupLabels': ['AMG 162']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}