Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-25 @ 5:43 PM
Study NCT ID:
NCT00984893
Status:
COMPLETED
Last Update Posted:
2016-03-04
First Post:
2009-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-venous Zoledronic Acid Once Yearly
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1551}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-03', 'studyFirstSubmitDate': '2009-09-23', 'studyFirstSubmitQcDate': '2009-09-24', 'lastUpdatePostDateStruct': {'date': '2016-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change in lumbar spine BMD as measured by dual energy x-ray absorptiometry (DXA)', 'timeFrame': '4 years'}], 'secondaryOutcomes': [{'measure': 'change in femoral neck BMD as measured by dual energy x-ray absorptiometry (DXA)', 'timeFrame': '4 years'}, {'measure': 'change in hip BMD as measured by dual energy x-ray absorptiometry (DXA)', 'timeFrame': '4 years'}, {'measure': 'Percent change in hip BMD as measured by dual energy x-ray absorptiometry (DXA)', 'timeFrame': '4 years'}, {'measure': 'Risk for fractures', 'timeFrame': '4 years'}, {'measure': 'Burden of illness, health care resource utilization, and loss of productivity', 'timeFrame': '4 years'}]}, 'conditionsModule': {'keywords': ['Osteoporosis', 'Bone Mineral density', 'fragility fractures', 'zoledronic acid.', 'Treatment'], 'conditions': ['Post-Menopausal Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The study will assess the real life effectiveness of zoledronic acid in the management of patients with osteoporosis over 4 years of treatment. Zoledronic acid will be compared to oral bisphosphonates (OBP) with respect to the change in Bone Mineral Density (BMD) and incidence of fractures.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ambulatory Female patients, at least 45 years of age, diagnosed with osteoporosis and taking either Zelodronic acid or any other oral bisphosphonates (OBP) as per the current Canadian monograph', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is an ambulatory female 45 years of age or older\n* Postmenopausal women with diagnosis of osteoporosis\n* Prescription of zoledronic acid or any OBP as per the current Canadian monograph\n* Must provide informed consent\n\nExclusion Criteria:\n\n* Any prior use of iv bisphosphonates within the last 2 years\n* Known secondary osteoporosis of any aetiology (hypogonadism in premenopausal women or premature menopause, malabsorption, chronic liver disease, inflammatory bowel disease)\n* Metabolic bone diseases such as primary or secondary hyperparathyroidism, hypoparathyroidism, Paget's disease of bone, Fibrous dysplasia..\n* Non-corrected hypocalcaemia at the time of zoledronic acid infusion\n* Creatinine clearance \\< or = 30 ml/min\n* Unwillingness or inability to comply with the study requirements\n* Concurrent participation in a clinical trial of an investigational drug, or within the last 30 days\n\nOther protocol-defined inclusion/exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT00984893', 'acronym': 'IVORY', 'briefTitle': 'Intra-venous Zoledronic Acid Once Yearly', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Real-world Study Cohort of Postmenopausal Women With Osteoporosis Taking Zoledronic Acid or Oral Bisphosphonates', 'orgStudyIdInfo': {'id': 'CZOL446HCA10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Zoledronic acid', 'interventionNames': ['Drug: zoledronic acid']}, {'label': 'Oral Bisphosphonates', 'interventionNames': ['Drug: Any oral bisphosphonates marketed in Canada']}], 'interventions': [{'name': 'zoledronic acid', 'type': 'DRUG', 'armGroupLabels': ['Zoledronic acid']}, {'name': 'Any oral bisphosphonates marketed in Canada', 'type': 'DRUG', 'armGroupLabels': ['Oral Bisphosphonates']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Groupe de recherche en rhumatologie et maladies osseuses Inc', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Marc Vaillancourt', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}