Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2026-01-01 @ 1:31 PM
Study NCT ID:
NCT00718861
Status:
COMPLETED
Last Update Posted:
2014-10-09
First Post:
2008-07-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China', 'Russia', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}, {'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': 'D000077211', 'term': 'Zoledronic Acid'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '8627788300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The safety population included all patients in the Intent to Treat (ITT) population who received at least 1 dose of study drug during this second extension study. Adverse Events data used the safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Z9 (Zoledronic Acid 9)', 'description': 'Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).', 'otherNumAtRisk': 92, 'otherNumAffected': 62, 'seriousNumAtRisk': 92, 'seriousNumAffected': 24}, {'id': 'EG001', 'title': 'Z6P3 (Zoledronic Acid 6 Placebo 3)', 'description': 'Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).', 'otherNumAtRisk': 95, 'otherNumAffected': 58, 'seriousNumAtRisk': 95, 'seriousNumAffected': 28}], 'otherEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Creatinine renal clearance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oesophageal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vestibular neuronitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fractured sacrum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pubis fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thoracic vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iron deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal tract adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Invasive lobular breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Uterine prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pemphigoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spinal fusion surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Z9 (Zoledronic Acid 9)', 'description': 'Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).'}, {'id': 'OG001', 'title': 'Z6P3 (Zoledronic Acid 6 Placebo 3)', 'description': 'Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.54', 'spread': '0.433', 'groupId': 'OG000'}, {'value': '-1.31', 'spread': '0.427', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Year 6 (baseline) and Year 9', 'description': "Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100\\*(Year 9 - Year 6)/Year 6.", 'unitOfMeasure': 'Percentage Change of BMD', 'dispersionType': 'Standard Error', 'populationDescription': 'The modified intent-to-treat (MITT) population included all patients in the ITT population who had DXA measurements of the total hip at Visit 11 (Year 6) and Visit 15 (Year 9). This was the primary population for the primary efficacy parameter.'}, {'type': 'SECONDARY', 'title': 'Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7 and 8 Compared to Year 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Z9 (Zoledronic Acid 9)', 'description': 'Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).'}, {'id': 'OG001', 'title': 'Z6P3 (Zoledronic Acid 6 Placebo 3)', 'description': 'Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).'}], 'classes': [{'title': 'Year 7 (n=83,76)', 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.336', 'groupId': 'OG000'}, {'value': '-0.83', 'spread': '0.347', 'groupId': 'OG001'}]}]}, {'title': 'Year 8 (n=73,72)', 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.311', 'groupId': 'OG000'}, {'value': '-1.06', 'spread': '0.315', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Year 6 (extension 2 baseline), Year 7, Year 8', 'description': "Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100\\*(Year 9 - Year 6)/Year 6.", 'unitOfMeasure': 'percentage change of BMD', 'dispersionType': 'Standard Error', 'populationDescription': 'The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 6 and follow-up visits as determined by the analysis window.'}, {'type': 'SECONDARY', 'title': 'Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Z9 (Zoledronic Acid 9)', 'description': 'Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).'}, {'id': 'OG001', 'title': 'Z6P3 (Zoledronic Acid 6 Placebo 3)', 'description': 'Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).'}], 'classes': [{'title': 'Year 7 (n=83,76)', 'categories': [{'measurements': [{'value': '-0.78', 'spread': '0.433', 'groupId': 'OG000'}, {'value': '-1.24', 'spread': '0.447', 'groupId': 'OG001'}]}]}, {'title': 'Year 8 (n=73,72)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.521', 'groupId': 'OG000'}, {'value': '-0.88', 'spread': '0.528', 'groupId': 'OG001'}]}]}, {'title': 'Year 9 (n=67,69)', 'categories': [{'measurements': [{'value': '-1.11', 'spread': '0.554', 'groupId': 'OG000'}, {'value': '-1.17', 'spread': '0.547', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Year 6 (extension 2 baseline), Year 7, Year 8, Year 9', 'description': "Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100\\*(Year 9 - Year 6)/Year 6.", 'unitOfMeasure': 'percentage change of BMD', 'dispersionType': 'Standard Error', 'populationDescription': 'The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 6 and follow-up visits as determined by the analysis window.'}, {'type': 'SECONDARY', 'title': 'Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Z9 (Zoledronic Acid 9)', 'description': 'Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).'}, {'id': 'OG001', 'title': 'Z6P3 (Zoledronic Acid 6 Placebo 3)', 'description': 'Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).'}], 'classes': [{'title': 'Year 7 (n=83,75)', 'categories': [{'measurements': [{'value': '4.81', 'spread': '0.619', 'groupId': 'OG000'}, {'value': '3.73', 'spread': '0.640', 'groupId': 'OG001'}]}]}, {'title': 'Year 8 (n=72,71)', 'categories': [{'measurements': [{'value': '5.35', 'spread': '0.677', 'groupId': 'OG000'}, {'value': '3.65', 'spread': '0.684', 'groupId': 'OG001'}]}]}, {'title': 'Year 9 (n=67,68)', 'categories': [{'measurements': [{'value': '4.64', 'spread': '0.760', 'groupId': 'OG000'}, {'value': '3.68', 'spread': '0.752', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Year 0 (core baseline), Year 7, Year 8, Year 9', 'description': "Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 0 = 100\\*(Year 9 - Year 0)/Year 0.", 'unitOfMeasure': 'percentage change of BMD', 'dispersionType': 'Standard Error', 'populationDescription': 'The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 0 and follow-up visits as determined by the analysis window.'}, {'type': 'SECONDARY', 'title': 'Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Z9 (Zoledronic Acid 9)', 'description': 'Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).'}, {'id': 'OG001', 'title': 'Z6P3 (Zoledronic Acid 6 Placebo 3)', 'description': 'Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).'}], 'classes': [{'title': 'Year 7 (n=83,75)', 'categories': [{'measurements': [{'value': '5.11', 'spread': '0.921', 'groupId': 'OG000'}, {'value': '3.86', 'spread': '0.952', 'groupId': 'OG001'}]}]}, {'title': 'Year 8 (n=72,71)', 'categories': [{'measurements': [{'value': '6.12', 'spread': '1.041', 'groupId': 'OG000'}, {'value': '4.43', 'spread': '1.052', 'groupId': 'OG001'}]}]}, {'title': 'Year 9 (n=67,68)', 'categories': [{'measurements': [{'value': '4.16', 'spread': '0.963', 'groupId': 'OG000'}, {'value': '3.88', 'spread': '0.954', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Year 0 (core baseline), Year 7, Year 8, Year 9', 'description': "Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 0 = 100\\*(Year 9 - Year 0)/Year 0.", 'unitOfMeasure': 'percentage change of BMD', 'dispersionType': 'Standard Error', 'populationDescription': 'The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at Year 0 and follow-up visits as determined by the analysis window.'}, {'type': 'SECONDARY', 'title': 'Biomarkers (Bone Markers) Serum C-terminal Telopeptide of Type I Collagen (CTx) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Z9 (Zoledronic Acid 9)', 'description': 'Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).'}, {'id': 'OG001', 'title': 'Z6P3 (Zoledronic Acid 6 Placebo 3)', 'description': 'Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).'}], 'classes': [{'title': 'Year 6 (n=59, 58)', 'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.6'}, {'value': '0.18', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '0.5'}]}]}, {'title': 'Year 7 (n=56, 51)', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.4'}, {'value': '0.22', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '0.5'}]}]}, {'title': 'Year 8 (n=51, 52)', 'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.4'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '0.4'}]}]}, {'title': 'Year 9 (n=51,54)', 'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.6'}, {'value': '0.22', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '0.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Year 6 (extension 2 baseline), Year 7, Year 8, Year 9', 'description': 'Bone marker analysis: All patients had blood samples collected for analysis of serum c-terminal telopeptide of type I collagen (CTx). Serum CTX assays measure a fragment of the C-terminal telopeptide of type 1 collagen released during resorption of mature bone', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Full Range', 'populationDescription': 'The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at each visit as determined by the analysis window.'}, {'type': 'SECONDARY', 'title': 'Biomarkers (Bone Markers)Serum N-terminal Propeptide of Type I Collagen (P1NP) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Z9 (Zoledronic Acid 9)', 'description': 'Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).'}, {'id': 'OG001', 'title': 'Z6P3 (Zoledronic Acid 6 Placebo 3)', 'description': 'Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).'}], 'classes': [{'title': 'Year 6 (n=88, 86)', 'categories': [{'measurements': [{'value': '25.89', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '69.1'}, {'value': '24.98', 'groupId': 'OG001', 'lowerLimit': '9.9', 'upperLimit': '65.6'}]}]}, {'title': 'Year 7 (n=58, 65)', 'categories': [{'measurements': [{'value': '25.69', 'groupId': 'OG000', 'lowerLimit': '12.3', 'upperLimit': '52.9'}, {'value': '27.79', 'groupId': 'OG001', 'lowerLimit': '11.7', 'upperLimit': '140.2'}]}]}, {'title': 'Year 8 (n=54, 57)', 'categories': [{'measurements': [{'value': '26.07', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '59.9'}, {'value': '25.19', 'groupId': 'OG001', 'lowerLimit': '13.1', 'upperLimit': '68.1'}]}]}, {'title': 'Year 9 (n=52,56)', 'categories': [{'measurements': [{'value': '26.74', 'groupId': 'OG000', 'lowerLimit': '12.4', 'upperLimit': '133.4'}, {'value': '27.41', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '119.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Year 6 (extension 2 baseline), Year 7, Year 8, Year 9', 'description': 'Bone marker analysis: All patients had blood samples collected for analysis of serum n-terminal propeptide of type I collagen (P1NP) The P1NP concentration is directly proportional to the amount of new collagen laid down during bone formation.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Full Range', 'populationDescription': 'The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at each visit as determined by the analysis window.'}, {'type': 'SECONDARY', 'title': 'Biomarkers (Bone Markers) Serum Bone-specific Alkaline Phosphatase (BSAP). at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Z9 (Zoledronic Acid 9)', 'description': 'Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).'}, {'id': 'OG001', 'title': 'Z6P3 (Zoledronic Acid 6 Placebo 3)', 'description': 'Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).'}], 'classes': [{'title': 'Year 6 (n=59, 62)', 'categories': [{'measurements': [{'value': '8.16', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '15.9'}, {'value': '8.95', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '16.2'}]}]}, {'title': 'Year 7 (n=58, 65)', 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '15.7'}, {'value': '10.00', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '19.6'}]}]}, {'title': 'Year 8 (n=54, 57)', 'categories': [{'measurements': [{'value': '7.84', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '16.4'}, {'value': '9.57', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '15.8'}]}]}, {'title': 'Year 9 (n=52, 56)', 'categories': [{'measurements': [{'value': '8.46', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '18.3'}, {'value': '9.94', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '20.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Year 6 (extension 2 baseline), Year 7, Year 8, Year 9', 'description': 'Bone marker analysis: All patients had blood samples collected for analysis of serum bone-specific alkaline phosphatase (BSAP).Bone-specific alkaline phosphatase (BSAP) is a useful marker of active bone formation.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Full Range', 'populationDescription': 'The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with measurements at each visit as determined by the analysis window.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With New/Worsening Morphometric Vertebral Fractures at Year 9 Compared to Year 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Z9 (Zoledronic Acid 9)', 'description': 'Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).'}, {'id': 'OG001', 'title': 'Z6P3 (Zoledronic Acid 6 Placebo 3)', 'description': 'Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).'}], 'classes': [{'title': 'New Morphometric vertebral fracture', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'New/worsening Morphometric vertebra', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Year 6 (extension 2 baseline), Year 9 (3 years of study duration)', 'description': 'Morphometric vertebral fracture (VF) was assessed based on morphometry. QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit, x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A fracture was defined as an SQ reading that was greater than the baseline SQ reading.', 'unitOfMeasure': 'participants', 'populationDescription': 'The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups. n= the number of patients with the event'}, {'type': 'SECONDARY', 'title': 'Mean of Time to First Clinical Fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Z9 (Zoledronic Acid 9)', 'description': 'Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).'}, {'id': 'OG001', 'title': 'Z6P3 (Zoledronic Acid 6 Placebo 3)', 'description': 'Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).'}], 'classes': [{'categories': [{'measurements': [{'value': '1212.05', 'spread': '22.96', 'groupId': 'OG000'}, {'value': '1204.65', 'spread': '26.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'over 3 years of study duration', 'description': 'The mean of time to the first clinical fracture is estimated from the area under the Kaplan-Meier curve.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Error', 'populationDescription': 'The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups.'}, {'type': 'SECONDARY', 'title': 'Change in Height at Years 7, 8 and 9 Relative to Year 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Z9 (Zoledronic Acid 9)', 'description': 'Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).'}, {'id': 'OG001', 'title': 'Z6P3 (Zoledronic Acid 6 Placebo 3)', 'description': 'Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).'}], 'classes': [{'title': 'Year 7 (n=58, 51)', 'categories': [{'measurements': [{'value': '-5.29', 'spread': '1.171', 'groupId': 'OG000'}, {'value': '-4.84', 'spread': '1.199', 'groupId': 'OG001'}]}]}, {'title': 'Year 8 (n=55, 49)', 'categories': [{'measurements': [{'value': '-10.16', 'spread': '1.875', 'groupId': 'OG000'}, {'value': '-9.90', 'spread': '2.006', 'groupId': 'OG001'}]}]}, {'title': 'Year 9 (n=52, 48)', 'categories': [{'measurements': [{'value': '-13.31', 'spread': '1.975', 'groupId': 'OG000'}, {'value': '-11.65', 'spread': '2.085', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Year 6 (extension 2 baseline), Year 7, Year 8, Year 9', 'description': 'Height was measured using a stadiometer in millimeters (mm). 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This included patients who were randomized to Z9 and Z6P3 groups. n = the number of patients with evaluable measurements at both Year 6 and the post-Year 6 visit, as determined by the analysis window.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Z9 (Zoledronic Acid 9)', 'description': 'Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).'}, {'id': 'FG001', 'title': 'Z6P3 (Zoledronic Acid 6 Placebo 3)', 'description': 'Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '"Started" indicates Randomized and Intent-to Treat (ITT) population', 'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'Safety Set', 'achievements': [{'comment': '3 patients randomized but never received study drug', 'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'Modified Intent to Treat', 'achievements': [{'comment': 'ITT patients with DXA total hip measure at extension 2 baseline and year 9', 'groupId': 'FG000', 'numSubjects': '67'}, {'comment': 'ITT patients with DXA total hip measure at extension 2 baseline and year 9', 'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Administrative Problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Z9 (Zoledronic Acid 9)', 'description': 'Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).'}, {'id': 'BG001', 'title': 'Z6P3 (Zoledronic Acid 6 Placebo 3)', 'description': 'Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '78', 'spread': '4.71', 'groupId': 'BG000'}, {'value': '78.1', 'spread': '4.85', 'groupId': 'BG001'}, {'value': '78.1', 'spread': '4.77', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups.'}}, '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': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-02', 'studyFirstSubmitDate': '2008-07-18', 'resultsFirstSubmitDate': '2013-11-08', 'studyFirstSubmitQcDate': '2008-07-18', 'lastUpdatePostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-08', 'studyFirstPostDateStruct': {'date': '2008-07-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9', 'timeFrame': 'Year 6 (baseline) and Year 9', 'description': "Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100\\*(Year 9 - Year 6)/Year 6."}], 'secondaryOutcomes': [{'measure': 'Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7 and 8 Compared to Year 6', 'timeFrame': 'Year 6 (extension 2 baseline), Year 7, Year 8', 'description': "Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100\\*(Year 9 - Year 6)/Year 6."}, {'measure': 'Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 6', 'timeFrame': 'Year 6 (extension 2 baseline), Year 7, Year 8, Year 9', 'description': "Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100\\*(Year 9 - Year 6)/Year 6."}, {'measure': 'Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0', 'timeFrame': 'Year 0 (core baseline), Year 7, Year 8, Year 9', 'description': "Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 0 = 100\\*(Year 9 - Year 0)/Year 0."}, {'measure': 'Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0', 'timeFrame': 'Year 0 (core baseline), Year 7, Year 8, Year 9', 'description': "Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 0 = 100\\*(Year 9 - Year 0)/Year 0."}, {'measure': 'Biomarkers (Bone Markers) Serum C-terminal Telopeptide of Type I Collagen (CTx) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9', 'timeFrame': 'Year 6 (extension 2 baseline), Year 7, Year 8, Year 9', 'description': 'Bone marker analysis: All patients had blood samples collected for analysis of serum c-terminal telopeptide of type I collagen (CTx). Serum CTX assays measure a fragment of the C-terminal telopeptide of type 1 collagen released during resorption of mature bone'}, {'measure': 'Biomarkers (Bone Markers)Serum N-terminal Propeptide of Type I Collagen (P1NP) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9', 'timeFrame': 'Year 6 (extension 2 baseline), Year 7, Year 8, Year 9', 'description': 'Bone marker analysis: All patients had blood samples collected for analysis of serum n-terminal propeptide of type I collagen (P1NP) The P1NP concentration is directly proportional to the amount of new collagen laid down during bone formation.'}, {'measure': 'Biomarkers (Bone Markers) Serum Bone-specific Alkaline Phosphatase (BSAP). at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9', 'timeFrame': 'Year 6 (extension 2 baseline), Year 7, Year 8, Year 9', 'description': 'Bone marker analysis: All patients had blood samples collected for analysis of serum bone-specific alkaline phosphatase (BSAP).Bone-specific alkaline phosphatase (BSAP) is a useful marker of active bone formation.'}, {'measure': 'Number of Participants With New/Worsening Morphometric Vertebral Fractures at Year 9 Compared to Year 6', 'timeFrame': 'Year 6 (extension 2 baseline), Year 9 (3 years of study duration)', 'description': 'Morphometric vertebral fracture (VF) was assessed based on morphometry. QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit, x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A fracture was defined as an SQ reading that was greater than the baseline SQ reading.'}, {'measure': 'Mean of Time to First Clinical Fracture', 'timeFrame': 'over 3 years of study duration', 'description': 'The mean of time to the first clinical fracture is estimated from the area under the Kaplan-Meier curve.'}, {'measure': 'Change in Height at Years 7, 8 and 9 Relative to Year 6', 'timeFrame': 'Year 6 (extension 2 baseline), Year 7, Year 8, Year 9', 'description': 'Height was measured using a stadiometer in millimeters (mm). A stadiometer is a piece of medical equipment used for measuring height. It is usually constructed out of a ruler and a sliding horizontal headpiece which is adjusted to rest on the top of the head.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Osteoporosis', 'zoledronic acid', 'post-menopausal'], 'conditions': ['Post-menopausal Osteoporosis']}, 'descriptionModule': {'briefSummary': 'This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who have received the 4th and 6th dose of zoledronic acid in study CZOL446H2301E1\n\nExclusion Criteria:\n\n* Poor kidney, eye, liver health\n* Use of certain therapies for osteoporosis in study CZOL446H2301E1\n* Abnormal calcium levels\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': 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