Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2026-01-04 @ 3:41 AM
Study NCT ID:
NCT03623633
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-07
First Post:
2018-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Antiresorptive Efficacy Discontinuation of Denosumab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-11', 'mcpReleaseN': 7, 'releaseDate': '2025-11-19'}], 'estimatedResultsFirstSubmitDate': '2025-11-19'}}, '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': 'D000069448', 'term': 'Denosumab'}, {'id': 'D019386', 'term': 'Alendronate'}, {'id': 'D020849', 'term': 'Raloxifene Hydrochloride'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-05', 'studyFirstSubmitDate': '2018-08-06', 'studyFirstSubmitQcDate': '2018-08-06', 'lastUpdatePostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum c-telopeptide (CTX)', 'timeFrame': 'Month 12 to 18 months', 'description': 'Change in serum CTX between month 12 and month 18'}, {'measure': 'Bone mineral density (BMD)', 'timeFrame': 'Month 24 to 36 months', 'description': 'Change in PA spine BMD between month 24 and month 36'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoporosis, Postmenopausal', 'Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '39112628', 'type': 'DERIVED', 'citation': 'Tsai JN, Jordan M, Lee H, Leder BZ. One versus 2 years of alendronate following denosumab: the CARD extension. Osteoporos Int. 2024 Dec;35(12):2225-2230. doi: 10.1007/s00198-024-07213-2. Epub 2024 Aug 7.'}]}, 'descriptionModule': {'briefSummary': 'Osteoporosis remains a significant healthcare burden for the United States. Current FDA-approved osteoporosis treatments include teriparatide, abaloparatide, bisphosphonates, denosumab, and raloxifene.\n\nDenosumab is a fully human monoclonal antibody that specifically binds to receptor activator of nuclear factor kappa-B ligand (RANKL). Denosumab potently suppresses osteoclastic activity but bone turnover rapidly normalizes and bone turnover marker levels can rebound above baseline levels after the drug is discontinued.\n\nThis study will help us determine the optimal duration and relative efficacy of two oral antiresorptive medications that are FDA-approved for treatment of postmenopausal osteoporosis (alendronate and raloxifene) in preventing the rebound increase in bone turnover that occurs after denosumab discontinuation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'genderBased': True, 'genderDescription': 'Postmenopausal women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women aged 45+\n* postmenopausal\n* osteoporotic with high risk of fracture as per National Osteoporosis Foundation guidelines\n\nExclusion Criteria:\n\n* no significant previous use of bone health modifying treatments\n* hip fracture within one year of enrollment\n* known congenital or acquired bone disease other than osteoporosis\n* significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease\n* abnormal calcium or parathyroid hormone level\n* serum vitamin D \\<20 ng/dL\n* anemia (hematocrit \\<32%)\n* history of malignancy (except non-melanoma skin carcinoma)\n* excessive alcohol use or substance abuse\n* extensive dental work involving extraction or dental implant within the past 6 months or in the upcoming 12 months\n* known contraindications to denosumab, alendronate, or raloxifene'}, 'identificationModule': {'nctId': 'NCT03623633', 'briefTitle': 'Comparative Antiresorptive Efficacy Discontinuation of Denosumab', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Comparative Antiresorptive Efficacy of Alendronate or Raloxifene Following Discontinuation of Denosumab', 'orgStudyIdInfo': {'id': '2018P001612'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Denosumab and Raloxifene', 'description': 'denosumab and raloxifene', 'interventionNames': ['Drug: denosumab', 'Drug: raloxifene']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Denosumab and Alendronate', 'description': 'denosumab and alendronate', 'interventionNames': ['Drug: denosumab', 'Drug: alendronate']}], 'interventions': [{'name': 'denosumab', 'type': 'DRUG', 'otherNames': ['Prolia'], 'description': 'denosumab 60 milligrams subcutaneously every 6 months', 'armGroupLabels': ['Denosumab and Alendronate', 'Denosumab and Raloxifene']}, {'name': 'alendronate', 'type': 'DRUG', 'otherNames': ['Fosamax'], 'description': 'alendronate 70 milligrams weekly', 'armGroupLabels': ['Denosumab and Alendronate']}, {'name': 'raloxifene', 'type': 'DRUG', 'otherNames': ['Evista'], 'description': 'raloxifene 60 milligrams daily', 'armGroupLabels': ['Denosumab and Raloxifene']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Joy Tsai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MGH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Harvard Medical School', 'investigatorFullName': 'Joy Tsai', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}