Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT00371956
Status:
COMPLETED
Last Update Posted:
2010-09-16
First Post:
2006-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy
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': 'D020849', 'term': 'Raloxifene Hydrochloride'}], 'ancestors': [{'id': 'D013629', 'term': 'Tamoxifen'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-15', 'studyFirstSubmitDate': '2006-09-01', 'studyFirstSubmitQcDate': '2006-09-01', 'lastUpdatePostDateStruct': {'date': '2010-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone turnover and bone mineral density', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Fracture, safety', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['raloxifene', 'estrogen', 'receptor', 'modulation', 'osteoporosis', 'steroid', 'Steroids'], 'conditions': ['Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '21187295', 'type': 'DERIVED', 'citation': 'Mok CC, Ying KY, To CH, Ho LY, Yu KL, Lee HK, Ma KM. Raloxifene for prevention of glucocorticoid-induced bone loss: a 12-month randomised double-blinded placebo-controlled trial. Ann Rheum Dis. 2011 May;70(5):778-84. doi: 10.1136/ard.2010.143453. Epub 2010 Dec 27.'}]}, 'descriptionModule': {'briefSummary': 'This study is a double-blind placebo-controlled trial evaluating the efficacy of raloxifene in the prevention of bone mineral density loss in patients receiving long term corticosteroids.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Postmenopausal patients with various chronic rheumatic diseases receiving chronic steroid therapy.\n2. Stable disease for at least 6 months prior to study with a stable dose of steroid (prednisone \\<= 10 mg/day or equivalent).\n3. Baseline bone mineral density (BMD) of the lumbar spine T score \\< -1.0.\n\nExclusion Criteria:\n\n1. Patients with a history of thromboembolism.\n2. Patients with positive antiphospholipid antibodies.\n3. History of allergic reactions or intolerance to raloxifene or other SERMs.\n4. Patients receiving bisphosphonates, parathyroid hormone, SERMs, anticonvulsants or anti-cytokine therapies within 6 months prior to study entry.\n5. Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.\n6. Patients with abnormal uterine bleeding of unknown etiology.\n7. Patients with serum creatinine level of \\>= 200 umol/L.'}, 'identificationModule': {'nctId': 'NCT00371956', 'briefTitle': 'Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tuen Mun Hospital'}, 'officialTitle': 'Raloxifene for Prevention of Bone Loss in Postmenopausal Patients Receiving Chronic Corticosteroid Therapy: a Randomized Double-blind Placebo-controlled Study', 'orgStudyIdInfo': {'id': 'HARECCTR0500058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'raloxifene', 'interventionNames': ['Drug: raloxifene']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'placebo arm', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'raloxifene', 'type': 'DRUG', 'description': '60mg/day', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'tab 1 daily', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'facility': 'Tuen Mun Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'CC MOK, MD, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tuen Mun Hospital Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tuen Mun Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'CC Mok', 'oldOrganization': 'Tuen Mun Hospital, Hong Kong'}}}}