Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2026-02-02 @ 7:59 AM
Study NCT ID:
NCT00909961
Status:
COMPLETED
Last Update Posted:
2017-03-21
First Post:
2009-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on Bone Mineral Density (BMD) in Postmenopausal Osteoporosis (PMO) Patients Between the Ages of 50 and 65 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2011-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-17', 'studyFirstSubmitDate': '2009-05-28', 'studyFirstSubmitQcDate': '2009-05-28', 'lastUpdatePostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy - BMD', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Efficacy - Biochemical markers', 'timeFrame': '6 months'}, {'measure': 'Safety - Rate of adverse events and serious adverse events', 'timeFrame': '6 months'}]}, 'conditionsModule': {'keywords': ['Osteoporosis', 'Bone Mineral Density', 'Biomarkers'], 'conditions': ['Postmenopausal Osteoporosis']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effects of zoledronic acid 5 mg infusion on BMD and biochemical markers of bone in post-menopausal osteoporotic patients aged between 50-65.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal osteoporosis\n* Patients who has a low bone mineral density at hip or vertebral\n* Patients who has an osteoporotic fracture at hip or vertebra\n\nExclusion Criteria:\n\n* Hypersensitivity either to the active substance or to any of the excipients or to any biphosphonates.\n* Known metabolic bone disease excluding osteoporosis.\n* Serious systemic disorder treated with drugs interfering with bone metabolism.\n* Significant liver or renal failure\n* Pathologic fracture in the examined body area or elsewhere.\n* Previous anti-osteoporotic treatment within 12 months or less prior to the recruitment.\n* Patients with hypocalcaemia\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00909961', 'briefTitle': 'A Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on Bone Mineral Density (BMD) in Postmenopausal Osteoporosis (PMO) Patients Between the Ages of 50 and 65 Years', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A One Year, Local, Open Label, Multicentre Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on BMD and Biochemical Markers of Bone in PMO Pts Between the Ages of 50 and 65 Years', 'orgStudyIdInfo': {'id': 'CZOL446HTR04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zoledronic acid', 'interventionNames': ['Drug: Zoledronic acid']}], 'interventions': [{'name': 'Zoledronic acid', 'type': 'DRUG', 'armGroupLabels': ['Zoledronic acid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigational site', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative site', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigational site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative site', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative site', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}, {'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative site', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}