Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-01-01 @ 9:05 AM
Study NCT ID:
NCT00051558
Status:
COMPLETED
Last Update Posted:
2009-03-12
First Post:
2003-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'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': 'D019379', 'term': 'Teriparatide'}, {'id': 'D019386', 'term': 'Alendronate'}], 'ancestors': [{'id': 'D010281', 'term': 'Parathyroid Hormone'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Teriparatide', 'description': 'Teriparatide 20 micrograms/day injection plus oral placebo, 36 months', 'otherNumAffected': 190, 'seriousNumAffected': 70}, {'id': 'EG001', 'title': 'Alendronate', 'description': 'Alendronate 10 mg/day oral plus injection placebo, 36 months', 'otherNumAffected': 177, 'seriousNumAffected': 64}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 44, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 23, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 32, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 22, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 24, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 29, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 21, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 23, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 24, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 27, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 31, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 26, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 23, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 25, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 28, 'numAffected': 26}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 23, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Epidermolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Inappropriate antidiuretic hormone secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Blindness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Enterovesical fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Reflux oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain', 'stats': [{'groupId': 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For 18, 24 and 36 month time points, no missing data were imputed. 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Least Squares Means from treatment.', 'testedNonInferiority': False}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for 18 months', 'groupDescription': 'Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\\*visit.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Least Squares Means obtained from the treatment\\*visit interaction term from the above mixed model repeated measures model.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '18, 24, 36 months, and 18 and 36 month endpoints', 'description': 'change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)', 'unitOfMeasure': 'grams per square centimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention-to-treat analysis was performed using all randomized and treated patients. For 18, 24 and 36 month time points, no missing data were imputed. However, at 18 and 36 month endpoints, last observation carried forward analyses were applied.'}, {'type': 'SECONDARY', 'title': 'Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': 'Teriparatide 20 micrograms/day injection plus oral placebo, 36 months'}, {'id': 'OG001', 'title': 'Alendronate', 'description': 'Alendronate 10 mg/day oral plus injection placebo, 36 months'}], 'classes': [{'title': 'Change from baseline at Month 36 (N=120,N=113)', 'categories': [{'measurements': [{'value': '0.041', 'spread': '0.005', 'groupId': 'OG000'}, {'value': '0.021', 'spread': '0.005', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at Month 24 (N=135,N=131)', 'categories': [{'measurements': [{'value': '0.030', 'spread': '0.005', 'groupId': 'OG000'}, {'value': '0.015', 'spread': '0.005', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at Month 18 (N=156,N=145)', 'categories': [{'measurements': [{'value': '0.028', 'spread': '0.005', 'groupId': 'OG000'}, {'value': '0.017', 'spread': '0.005', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at Month 12 (N=167,N=158)', 'categories': [{'measurements': [{'value': '0.026', 'spread': '0.005', 'groupId': 'OG000'}, {'value': '0.012', 'spread': '0.005', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for 12 months', 'groupDescription': 'Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\\*visit.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Least Squares Means obtained from the treatment\\*visit interaction term from the above mixed model repeated measures model.', 'testedNonInferiority': False}, {'pValue': '0.015', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for 18 months', 'groupDescription': 'Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\\*visit.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Least Squares Means obtained from the treatment\\*visit interaction term from the above mixed model repeated measures model.', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for 24 months', 'groupDescription': 'Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\\*visit.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Least Squares Means obtained from the treatment\\*visit interaction term from the above mixed model repeated measures model.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for 36 months', 'groupDescription': 'Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\\*visit.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Least Squares Means obtained from the treatment\\*visit interaction term from the above mixed model repeated measures model.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12, 18, 24, and 36 months', 'description': 'change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)', 'unitOfMeasure': 'grams per square centimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.'}, {'type': 'SECONDARY', 'title': 'Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': 'Teriparatide 20 micrograms/day injection plus oral placebo, 36 months'}, {'id': 'OG001', 'title': 'Alendronate', 'description': 'Alendronate 10 mg/day oral plus injection placebo, 36 months'}], 'classes': [{'title': 'Change from baseline at 36 Months (N=120, N=113)', 'categories': [{'measurements': [{'value': '0.037', 'spread': '0.005', 'groupId': 'OG000'}, {'value': '0.020', 'spread': '0.005', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at 24 Months (N=135, N=131)', 'categories': [{'measurements': [{'value': '0.034', 'spread': '0.004', 'groupId': 'OG000'}, {'value': '0.018', 'spread': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at 18 Months (N=156, N=145)', 'categories': [{'measurements': [{'value': '0.027', 'spread': '0.004', 'groupId': 'OG000'}, {'value': '0.018', 'spread': '0.004', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline at 12 Months (N=167, N=158)', 'categories': [{'measurements': [{'value': '0.022', 'spread': '0.004', 'groupId': 'OG000'}, {'value': '0.014', 'spread': '0.004', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for 12 months', 'groupDescription': 'Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\\*visit.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Least Squares Means obtained from the treatment\\*visit interaction term from the above mixed model repeated measures model.', 'testedNonInferiority': False}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for 18 months', 'groupDescription': 'Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\\*visit.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Least Squares Means obtained from the treatment\\*visit interaction term from the above mixed model repeated measures model.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for 24 months', 'groupDescription': 'Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\\*visit.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Least Squares Means obtained from the treatment\\*visit interaction term from the above mixed model repeated measures model.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for 36 months', 'groupDescription': 'Mixed Model Repeated Measures: Change in BMD=treatment+region+prior bisphosphonate use+gender+baseline BMD+visit+treatment\\*visit.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Least Squares Means obtained from the treatment\\*visit interaction term from the above mixed model repeated measures model.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12, 18, 24, and 36 months', 'description': 'change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)', 'unitOfMeasure': 'grams per square centimeters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention-to-treat analysis was performed using all randomized and treated patients. No missing data was imputed.'}, {'type': 'SECONDARY', 'title': 'Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': 'Teriparatide 20 micrograms/day injection plus oral placebo, 36 months'}, {'id': 'OG001', 'title': 'Alendronate', 'description': 'Alendronate 10 mg/day oral plus injection placebo, 36 months'}], 'classes': [{'title': 'Percent change from baseline at Month 1(N=98,N=99)', 'categories': [{'measurements': [{'value': '107.0', 'spread': '13.744', 'groupId': 'OG000'}, {'value': '-14.8', 'spread': '2.861', 'groupId': 'OG001'}]}]}, {'title': 'Percent change from baseline at Month 6(N=86,N=85)', 'categories': [{'measurements': [{'value': '130.8', 'spread': '20.752', 'groupId': 'OG000'}, {'value': '-43.2', 'spread': '3.481', 'groupId': 'OG001'}]}]}, {'title': 'Percent change from baseline at Month18(N=77,N=76)', 'categories': [{'measurements': [{'value': '86.3', 'spread': '20.231', 'groupId': 'OG000'}, {'value': '-35.8', 'spread': '4.477', 'groupId': 'OG001'}]}]}, {'title': 'Percent change from baseline at Month36(N=59,N=57)', 'categories': [{'measurements': [{'value': '61.7', 'spread': '16.156', 'groupId': 'OG000'}, {'value': '-20.2', 'spread': '10.587', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Month 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Wilcoxon Rank Sum Test using the aligned ranks for scores.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Month 6', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Wilcoxon Rank Sum Test using the aligned ranks for scores.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Month 18', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Wilcoxon Rank Sum Test using the aligned ranks for scores.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Month 36', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Wilcoxon Rank Sum Test using the aligned ranks for scores.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1, 6, 18, and 36 months', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of patients with measures of biochemical markers'}, {'type': 'SECONDARY', 'title': 'Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': 'Teriparatide 20 micrograms/day injection plus oral placebo, 36 months'}, {'id': 'OG001', 'title': 'Alendronate', 'description': 'Alendronate 10 mg/day oral plus injection placebo, 36 months'}], 'classes': [{'title': 'Percent change from baseline at Month 1(N=66,N=78)', 'categories': [{'measurements': [{'value': '48.2', 'spread': '7.024', 'groupId': 'OG000'}, {'value': '-8.8', 'spread': '2.912', 'groupId': 'OG001'}]}]}, {'title': 'Percent change from baseline at Month 6(N=67,N=76)', 'categories': [{'measurements': [{'value': '10.5', 'spread': '5.318', 'groupId': 'OG000'}, {'value': '-22.3', 'spread': '3.694', 'groupId': 'OG001'}]}]}, {'title': 'Percent change from baseline at Month18(N=55,N=65)', 'categories': [{'measurements': [{'value': '5.1', 'spread': '8.604', 'groupId': 'OG000'}, {'value': '-21.3', 'spread': '4.207', 'groupId': 'OG001'}]}]}, {'title': 'Percent change from baseline at Month36(N=45,N=49)', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '7.082', 'groupId': 'OG000'}, {'value': '-15.4', 'spread': '7.394', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Month 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Wilcoxon Rank Sum Test using the aligned ranks for scores.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Month 6', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Wilcoxon Rank Sum Test using the aligned ranks for scores.', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Month 18', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Wilcoxon Rank Sum Test using the aligned ranks for scores.', 'testedNonInferiority': False}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Month 36', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Wilcoxon Rank Sum Test using the aligned ranks for scores.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1, 6, 18, and 36 months', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of patients with measures of biochemical markers.'}, {'type': 'SECONDARY', 'title': 'Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': 'Teriparatide 20 micrograms/day injection plus oral placebo, 36 months'}, {'id': 'OG001', 'title': 'Alendronate', 'description': 'Alendronate 10 mg/day oral plus injection placebo, 36 months'}], 'classes': [{'title': 'Percent change from baseline at Month 1(N=65,N=78)', 'categories': [{'measurements': [{'value': '35.0', 'spread': '7.518', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '4.897', 'groupId': 'OG001'}]}]}, {'title': 'Percent change from baseline at Month 6(N=66,N=76)', 'categories': [{'measurements': [{'value': '52.3', 'spread': '10.995', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '12.384', 'groupId': 'OG001'}]}]}, {'title': 'Percent change from baseline at Month18(N=54,N=65)', 'categories': [{'measurements': [{'value': '34.4', 'spread': '9.548', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '10.501', 'groupId': 'OG001'}]}]}, {'title': 'Percent change from baseline at Month36(N=44,N=49)', 'categories': [{'measurements': [{'value': '44.7', 'spread': '14.357', 'groupId': 'OG000'}, {'value': '20.6', 'spread': '19.912', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Month 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Wilcoxon Rank Sum Test using the aligned ranks for scores.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Month 6', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Wilcoxon Rank Sum Test using the aligned ranks for scores.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Month 18', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Wilcoxon Rank Sum Test using the aligned ranks for scores.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Month 36', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Wilcoxon Rank Sum Test using the aligned ranks for scores.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1, 6, 18, and 36 months', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of patients with measures of biochemical markers'}, {'type': 'SECONDARY', 'title': 'Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': 'Teriparatide 20 micrograms/day injection plus oral placebo, 36 months'}, {'id': 'OG001', 'title': 'Alendronate', 'description': 'Alendronate 10 mg/day oral plus injection placebo, 36 months'}], 'classes': [{'title': 'Percent change from baseline at Month 1(N=70,N=79)', 'categories': [{'measurements': [{'value': '29.0', 'spread': '8.192', 'groupId': 'OG000'}, {'value': '-38.6', 'spread': '4.110', 'groupId': 'OG001'}]}]}, {'title': 'Percent change from baseline at Month 6(N=66,N=75)', 'categories': [{'measurements': [{'value': '66.8', 'spread': '17.143', 'groupId': 'OG000'}, {'value': '-42.4', 'spread': '5.050', 'groupId': 'OG001'}]}]}, {'title': 'Percent change from baseline at Month18(N=64,N=71)', 'categories': [{'measurements': [{'value': '29.1', 'spread': '11.714', 'groupId': 'OG000'}, {'value': '-47.5', 'spread': '6.305', 'groupId': 'OG001'}]}]}, {'title': 'Percent change from baseline at Month36(N=49,N=48)', 'categories': [{'measurements': [{'value': '30.7', 'spread': '14.205', 'groupId': 'OG000'}, {'value': '-16.2', 'spread': '23.178', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Month 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Wilcoxon Rank Sum Test using the aligned ranks for scores.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Month 6', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Wilcoxon Rank Sum Test using the aligned ranks for scores.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Month 18', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Wilcoxon Rank Sum Test using the aligned ranks for scores.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Month 36', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Wilcoxon Rank Sum Test using the aligned ranks for scores.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1, 6, 18, and 36 months', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Subset of patients with measures of biochemical markers'}, {'type': 'SECONDARY', 'title': 'Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Teriparatide', 'description': 'Teriparatide 20 micrograms/day injection plus oral placebo, 36 months'}, {'id': 'OG001', 'title': 'Alendronate', 'description': 'Alendronate 10 mg/day oral plus injection placebo, 36 months'}], 'classes': [{'title': 'Percent change from baseline at Month1(N=94,N=100)', 'categories': [{'measurements': [{'value': '147.1', 'spread': '26.408', 'groupId': 'OG000'}, {'value': '-5.2', 'spread': '3.447', 'groupId': 'OG001'}]}]}, {'title': 'Percent change from baseline at Month 6(N=84,N=88)', 'categories': [{'measurements': [{'value': '120.0', 'spread': '16.713', 'groupId': 'OG000'}, {'value': '-33.6', 'spread': '3.656', 'groupId': 'OG001'}]}]}, {'title': 'Percent change from baseline at Month18(N=77,N=77)', 'categories': [{'measurements': [{'value': '108.9', 'spread': '22.750', 'groupId': 'OG000'}, {'value': '-25.0', 'spread': '5.118', 'groupId': 'OG001'}]}]}, {'title': 'Percent change from baseline at Month36(N=56,N=58)', 'categories': [{'measurements': [{'value': '62.1', 'spread': '20.929', 'groupId': 'OG000'}, {'value': '-19.6', 'spread': '12.980', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Month 1', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Wilcoxon Rank Sum Test using the aligned ranks for scores.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value at Month 6', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 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'resultsFirstPostDateStruct': {'date': '2009-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)', 'timeFrame': '18 month endpoint', 'description': 'change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset', 'timeFrame': '18 month endpoint', 'description': 'change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)'}, {'measure': 'Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined', 'timeFrame': '3, 6, 12, 18, 24, 36 months', 'description': 'change from baseline in bone 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'Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined', 'timeFrame': '18, 24, 36 months, and 18 and 36 month endpoints', 'description': 'change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)'}, {'measure': 'Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined', 'timeFrame': '12, 18, 24, and 36 months', 'description': 'change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)'}, {'measure': 'Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined', 'timeFrame': '12, 18, 24, and 36 months', 'description': 'change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)'}, {'measure': 'Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal 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Trabecular Bone Score in Patients With Chronic Glucocorticoid Therapy-Induced Osteoporosis Treated With Alendronate or Teriparatide. Arthritis Rheumatol. 2016 Sep;68(9):2122-8. doi: 10.1002/art.39726.'}, {'pmid': '19918047', 'type': 'DERIVED', 'citation': 'Devogelaer JP, Adler RA, Recknor C, See K, Warner MR, Wong M, Krohn K. Baseline glucocorticoid dose and bone mineral density response with teriparatide or alendronate therapy in patients with glucocorticoid-induced osteoporosis. J Rheumatol. 2010 Jan;37(1):141-8. doi: 10.3899/jrheum.090411. Epub 2009 Nov 16.'}, {'pmid': '18003959', 'type': 'DERIVED', 'citation': 'Saag KG, Shane E, Boonen S, Marin F, Donley DW, Taylor KA, Dalsky GP, Marcus R. Teriparatide or alendronate in glucocorticoid-induced osteoporosis. N Engl J Med. 2007 Nov 15;357(20):2028-39. doi: 10.1056/NEJMoa071408.'}], 'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures. Glucocorticoids (such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma. When taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called "glucocorticoid-induced osteoporosis." 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5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'city': 'Jamestown', 'state': 'North Dakota', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 46.91054, 'lon': -98.70844}}, {'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Graz', 'country': 'Austria', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Aarhus', 'country': 'Denmark', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Carolina', 'country': 'Puerto Rico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 18.38078, 'lon': -65.95739}}, {'city': 'Ponce', 'country': 'Puerto Rico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Chief Medical Officer', 'oldOrganization': 'Eli Lilly'}}}}