Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-28 @ 5:41 AM
Study NCT ID:
NCT02271204
Status:
COMPLETED
Last Update Posted:
2014-10-22
First Post:
2014-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of iv Ibandronate in Women With Postmenopausal Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': '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': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-20', 'studyFirstSubmitDate': '2014-10-07', 'studyFirstSubmitQcDate': '2014-10-20', 'lastUpdatePostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability of intravenous Ibandronate intermittent administration in patients with postmenopausal osteoporosis', 'timeFrame': 'end of observation 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'This observational study assess the safety of intravenous Ibandronate (Bonviva) intermittent administration in patients with postmenopausal osteoporosis and the efficacy of IV Ibandronate (Bonviva treatment through relative lumbar spine and hip bone mineral densitometry form baseline at year 1)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women with postmenopausal osteoporosis in everyday routine practice from selected centers in R. Macedonia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients had post menopausal osteoporosis\n* Patients had no contraindication for bisphosphonates\n* Patients had been naive for ibandronate therapy\n* Patients who have signed informed consent and are willing to share their data for data analysis\n\nExclusion Criteria:\n\n* Is not Ibandronate naïve\n* Hypersensitivity to any component of the bisphosphonates Ibandronate;\n* Administration of any investigational drug within 30 days preceding the first dose of the study drug.'}, 'identificationModule': {'nctId': 'NCT02271204', 'briefTitle': 'Observational Study of iv Ibandronate in Women With Postmenopausal Osteoporosis', 'organization': {'class': 'OTHER', 'fullName': 'Clinic of Endocrinology and Metabolic Disorders, Macedonia'}, 'officialTitle': 'Post Authorization Safety Study of iv Ibandronate (Bonviva) in Postmenopausal Osteoporosis, Observational, Non-interventional Open Label Trial', 'orgStudyIdInfo': {'id': 'ML21741'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ibandronic acid', 'type': 'DRUG', 'otherNames': ['Bonviva'], 'description': 'As prescribed by physician'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinic of Endocrinology and Metabolic Disorders, Macedonia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinic for Orthopedic Surgery, Skopje', 'class': 'UNKNOWN'}, {'name': 'General Hospital, Kumanovo', 'class': 'UNKNOWN'}, {'name': 'General Hospital, Struga', 'class': 'UNKNOWN'}, {'name': 'Medical Faculty, Institute for Epidemiology and Biostatistics, Skopje', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}