Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT00330460
Status:
COMPLETED
Last Update Posted:
2011-01-24
First Post:
2006-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Australia', 'Belgium', 'Brazil', 'Canada', 'Denmark', 'Germany', 'Spain', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019386', 'term': 'Alendronate'}, {'id': 'D000069448', 'term': 'Denosumab'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 months', 'description': 'The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Alendronate 70 mg QW', 'otherNumAtRisk': 586, 'otherNumAffected': 261, 'seriousNumAtRisk': 586, 'seriousNumAffected': 37}, {'id': 'EG001', 'title': 'Denosumab 60 mg Q6M', 'otherNumAtRisk': 593, 'otherNumAffected': 270, 'seriousNumAtRisk': 593, 'seriousNumAffected': 34}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 41}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 45}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 75}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 42}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 31}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 30}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ventricular asystole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Macular hole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Retinal tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastric ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Infected cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pseudomembranous colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chondromalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Benign breast neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cholesteatoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fibroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Mycosis fungoides', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ovarian cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Renal cell carcinoma stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Small cell lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vaginal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypoglycaemic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Activities of daily living impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 586, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 593, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Hip Bone Mineral Density Percent Change From Baseline at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '572', 'groupId': 'OG000'}, {'value': '579', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alendronate 70 mg QW'}, {'id': 'OG001', 'title': 'Denosumab 60 mg Q6M'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '2.8'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '3.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '0.7', 'ciUpperLimit': '1.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority margin = -1.22%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.', 'unitOfMeasure': 'Percent Change from Baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized subjects who have a nonmissing baseline and at least 1 nonmissing postbaseline evaluation at or prior to month 12. LOCF used as imputation method.'}, {'type': 'SECONDARY', 'title': 'Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '571', 'groupId': 'OG000'}, {'value': '579', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alendronate 70 mg QW'}, {'id': 'OG001', 'title': 'Denosumab 60 mg Q6M'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '4.5'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '5.6'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.7', 'ciUpperLimit': '1.4', 'pValueComment': 'The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority margin = -2.29%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.', 'unitOfMeasure': 'Percent Change from Baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Trochanter Bone Mineral Density Percent Change From Baseline at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '572', 'groupId': 'OG000'}, {'value': '579', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alendronate 70 mg QW'}, {'id': 'OG001', 'title': 'Denosumab 60 mg Q6M'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '3.7'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '4.8'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '0.6', 'ciUpperLimit': '1.4', 'pValueComment': 'The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority margin = -1.65%'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.', 'unitOfMeasure': 'Percent Change from Baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '572', 'groupId': 'OG000'}, {'value': '579', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alendronate 70 mg QW'}, {'id': 'OG001', 'title': 'Denosumab 60 mg Q6M'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '2.1'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '2.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.3', 'ciUpperLimit': '1', 'pValueComment': 'The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority margin = -1.04%'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.', 'unitOfMeasure': 'Percent Change from Baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'OG000'}, {'value': '573', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alendronate 70 mg QW'}, {'id': 'OG001', 'title': 'Denosumab 60 mg Q6M'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.8'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '1.4'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.3', 'ciUpperLimit': '0.9', 'pValueComment': 'The reported p-value was the one-sided adjusted p-valued based on multiplicity adjustment of the secondary efficacy endpoints', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.', 'unitOfMeasure': 'Percent Change from Baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alendronate 70 mg QW'}, {'id': 'FG001', 'title': 'Denosumab 60 mg Q6M'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '595'}, {'groupId': 'FG001', 'numSubjects': '594'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '553'}, {'groupId': 'FG001', 'numSubjects': '561'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Ineligibility determined', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First Subject Enrolled: 26-Apr-2006 Last Subject Enrolled: 17-Nov-2006'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '595', 'groupId': 'BG000'}, {'value': '594', 'groupId': 'BG001'}, {'value': '1189', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Alendronate 70 mg QW'}, {'id': 'BG001', 'title': 'Denosumab 60 mg Q6M'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.6', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '64.1', 'spread': '8.6', 'groupId': 'BG001'}, {'value': '64.4', 'spread': '8.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '595', 'groupId': 'BG000'}, {'value': '594', 'groupId': 'BG001'}, {'value': '1189', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White or Caucasian', 'categories': [{'measurements': [{'value': '502', 'groupId': 'BG000'}, {'value': '502', 'groupId': 'BG001'}, {'value': '1004', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Japanese', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'dispFirstSubmitDate': '2009-11-23', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-20', 'studyFirstSubmitDate': '2006-04-06', 'dispFirstSubmitQcDate': '2009-11-23', 'resultsFirstSubmitDate': '2010-06-18', 'studyFirstSubmitQcDate': '2006-05-24', 'dispFirstPostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-01-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-06-18', 'studyFirstPostDateStruct': {'date': '2006-05-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Hip Bone Mineral Density Percent Change From Baseline at Month 12', 'timeFrame': '12 months', 'description': 'Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.'}], 'secondaryOutcomes': [{'measure': 'Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12', 'timeFrame': '12 months', 'description': 'Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.'}, {'measure': 'Trochanter Bone Mineral Density Percent Change From Baseline at Month 12', 'timeFrame': '12 months', 'description': 'Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.'}, {'measure': 'Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12', 'timeFrame': '12 months', 'description': 'Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.'}, {'measure': 'Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12', 'timeFrame': '12 months', 'description': 'Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.'}]}, 'conditionsModule': {'keywords': ['Osteoporosis', 'Osteopenia', 'AMG 162', 'Fracture - hip', 'Postmenopausal'], 'conditions': ['Osteoporosis', 'Osteopenia']}, 'referencesModule': {'references': [{'pmid': '18767928', 'type': 'RESULT', 'citation': 'Brown JP, Prince RL, Deal C, Recker RR, Kiel DP, de Gregorio LH, Hadji P, Hofbauer LC, Alvaro-Gracia JM, Wang H, Austin M, Wagman RB, Newmark R, Libanati C, San Martin J, Bone HG. Comparison of the effect of denosumab and alendronate on BMD and biochemical markers of bone turnover in postmenopausal women with low bone mass: a randomized, blinded, phase 3 trial. J Bone Miner Res. 2009 Jan;24(1):153-61. doi: 10.1359/jbmr.0809010.'}, {'pmid': '22152181', 'type': 'DERIVED', 'citation': 'Gold DT, Horne R, Coon CD, Price MA, Borenstein J, Varon SF, Satram-Hoang S, Macarios D. Development, reliability, and validity of a new Preference and Satisfaction Questionnaire. Value Health. 2011 Dec;14(8):1109-16. doi: 10.1016/j.jval.2011.06.010. Epub 2011 Oct 1.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}, {'url': 'http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf', 'label': 'Notice regarding posted summaries of trial results'}, {'url': 'http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_49_AMG_162_20050141.pdf', 'label': 'To access clinical trial results information click on this link'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether in postmenopausal women with low bone mineral density, the mean percent change in total hip BMD in subjects receiving denosumab is not less than that observed in subjects receiving alendronate sodium by more than a pre-specified non-inferiority margin.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: - Patient is an ambulatory postmenopausal woman - Patient has BMD value that corresponds to a T-score of less than or equal to -2.0 (g/cm2) at the lumbar spine OR total hip within range specific to the study protocol. Exclusion Criteria: o Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures\n\n* Evidence of any of the following per subject report, chart review or central laboratory result:\n\n 1. Hyper- or hypothyroidism; however, subjects on stable thyroid hormone replacement therapy may be allowed per the following criteria:\n\n * If TSH level is normal, subject is eligible for the study.\n * If TSH level is below normal range, subject is not eligible for the study.\n * If TSH level is elevated (\\> 5.5 mIU/mL to 10.0 mIU/mL), serum T4 should be measured. If serum T4 is within normal range, subject is eligible. If serum T4 is outside of normal range, subject is not eligible for the study.\n * If TSH level is above 10.0 mIU/mL, subject is not eligible.\n 2. Current hyper- or hypoparathyroidism\n 3. Elevated transaminases\n\n * Serum aspartate aminotransferase (AST; serum glutamate-oxaloacetic transaminase \\[SGOT\\]) ³ 2.0 x upper limits of normal (ULN)\n * Serum alanine aminotransferase (ALT; serum glutamate-pyruvate transaminase \\[SGPT\\]) ³ 2.0 x ULN\n 4. Significantly impaired renal function as determined by serum creatinine ³ 2.0 mg/dL\n 5. Current hypo- or hypercalcemia based on the central laboratory reference ranges\n 6. Active gastric or duodenal ulcer; history of significant gastrointestinal bleed requiring hospitalization or transfusion, or dyspepsia or gastroesophageal reflux disease that is uncontrolled by medication\n 7. Rheumatoid Arthritis, Paget's disease, Cushing's disease, hyperprolactinemia, or cirrhosis of the liver\n 8. Known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen\n 9. Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years\n 10. Any metabolic bone disease, eg, osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings\n 11. Malabsorption syndrome or any gastrointestinal disorders that are associated with malabsorption\n* Received any solid organ or bone marrow transplant\n* Vitamin D deficiency (25(OH) vitamin D level \\< 12 ng/mL). Vitamin D repletion will be permitted and subjects may be re-screened; see Section 7.\n* Any laboratory abnormality which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results\n* Contraindicated or poorly tolerant of ALN therapy; contraindications for ALN therapy include:\n\n 1. Abnormalities of the esophagus, which delay esophageal emptying such as stricture or achalasia.\n 2. Inability to stand or sit upright for at least 30 minutes.\n 3. Hypersensitivity to ALN or other constituents of ALN tablets o Known sensitivity to mammalian cell derived drug products\n* Known intolerance to calcium supplements\n* Administration of intravenous bisphosphonate, or fluoride (except for dental treatment) or strontium ranelate\n* Oral bisphosphonate treatment:\n\n * ³ 3 months cumulatively in the past 2 years, OR\n * ³ 1 month in the past year, OR\n * Any use during the 3-month period prior to randomization\n* PTH or PTH derivatives (eg, teriparatide) within the last year\n* Administration of any of the following treatments within 3 months of randomization:\n\n 1. Any SERM (eg, raloxifene)\n 2. Tibolone\n 3. Anabolic steroids or testosterone\n 4. Glucocorticosteroids (³ 5 mg prednisone equivalent per day for more than 10 days)\n 5. Systemic (oral, transdermal, topical) hormone replacement therapy (local vaginal estrogen preparation will be allowed)\n 6. Calcitonin\n 7. Calcitriol or vitamin D derivatives\n 8. Other bone active drugs including anti-convulsives (except benzodiazepines) and heparin\n 9. Chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone agonists\n 10. Height, weight or girth which may preclude accurate DXA measurements\n* Less than 2 lumbar vertebrae (L1-L4) evaluable for DXA measurements\n* Both hips not evaluable by DXA (eg, history of bilateral hip replacement or pins in both hips)\n* Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)\n* Any physical or psychiatric disorder which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results\n* Evidence of alcohol or substance-abuse within the last 12 months which the investigator believes would interfere with understanding or completing the study"}, 'identificationModule': {'nctId': 'NCT00330460', 'briefTitle': 'A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Denisty', 'orgStudyIdInfo': {'id': '20050141'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Alendronate', 'description': 'Subjects in this arm will receive active ALN and placebo denosumab', 'interventionNames': ['Drug: Alendronate']}, {'type': 'EXPERIMENTAL', 'label': 'Denosumab', 'description': 'Subjects in this arm will receive active denosumab and placbo ALN', 'interventionNames': ['Drug: Denosumab']}], 'interventions': [{'name': 'Alendronate', 'type': 'DRUG', 'description': 'ALN; 70 mg; oral; once weekly', 'armGroupLabels': ['Alendronate']}, {'name': 'Denosumab', 'type': 'DRUG', 'description': '60 mg; SC; every 6 months', 'armGroupLabels': ['Denosumab']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Global Development Leader', 'oldOrganization': 'Amgen Inc.'}}}}