Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-02-24 @ 8:26 AM
Study NCT ID:
NCT00493532
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2016-11-02
First Post:
2007-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015663', 'term': 'Osteoporosis, Postmenopausal'}], 'ancestors': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'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': 'D000077557', 'term': 'Ibandronic Acid'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2007-06-27', 'studyFirstSubmitQcDate': '2007-06-27', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Postmenopausal Osteoporosis']}, 'descriptionModule': {'briefSummary': 'This single arm study will assess the efficacy and safety of quarterly intravenous Bonviva in women with post-menopausal osteoporosis. All patients will receive Bonviva 3mg i.v. every 3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* post-menopausal women with osteoporosis;\n* \\<=80 years of age;\n* naive to oral bisphosphonates, or have discontinued daily and/or weekly bisphosphonate treatment for \\>1 year.\n\nExclusion Criteria:\n\n* metabolic bone disease other than post-menopausal osteoporosis;\n* treatment with other drugs affecting bone metabolism within last 6 months;\n* previous or current malignant disease (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer).'}, 'identificationModule': {'nctId': 'NCT00493532', 'briefTitle': 'A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open Label Study to Evaluate the Effect on Bone Mineral Density, and the Safety, of Quarterly Intravenous Bonviva in Patients With Post-menopausal Osteoporosis.', 'orgStudyIdInfo': {'id': 'ML20882'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ibandronate [Bonviva/Boniva]', 'type': 'DRUG', 'description': '3mg iv every 3 months'}]}, 'contactsLocationsModule': {'locations': [{'zip': '613', 'city': 'Chai Yi', 'country': 'Taiwan'}, {'zip': '500', 'city': 'Changhua', 'country': 'Taiwan', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}, {'zip': '00833', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '804', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '402', 'city': 'Taichung', 'country': 'Taiwan', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '404', 'city': 'Taichung', 'country': 'Taiwan', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '40705', 'city': 'Taichung', 'country': 'Taiwan', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '704', 'city': 'Tainan', 'country': 'Taiwan', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '710', 'city': 'Tainan', 'country': 'Taiwan', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '00112', 'city': 'Taipei', 'country': 'Taiwan', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '886', 'city': 'Taipei', 'country': 'Taiwan', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}