{"id":"denosumab-de-escalation","safety":{"commonSideEffects":[{"rate":null,"effect":"Osteonecrosis of the jaw"},{"rate":null,"effect":"Atypical fractures"},{"rate":null,"effect":"Hypocalcemia"},{"rate":null,"effect":"Infection"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Denosumab is a monoclonal antibody that inhibits RANKL (receptor activator of nuclear factor kappa-B ligand), thereby suppressing osteoclast formation and bone resorption. De-escalation involves lowering the dose or extending dosing intervals to reduce cumulative exposure and associated risks such as osteonecrosis of the jaw, atypical fractures, and hypocalcemia, while preserving efficacy in conditions like osteoporosis and bone metastases.","oneSentence":"Denosumab de-escalation is a treatment strategy that reduces the dose or frequency of denosumab (a RANKL inhibitor) to minimize long-term adverse effects while maintaining therapeutic benefit in bone disease.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:44:16.721Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Osteoporosis management with reduced dosing"},{"name":"Bone metastases with de-escalated dosing to reduce adverse effects"}]},"trialDetails":[{"nctId":"NCT02051218","phase":"PHASE3","title":"Prevention of Symptomatic Skeletal Events With Denosumab Administered Every 4 Weeks Versus Every 12 Weeks","status":"ACTIVE_NOT_RECRUITING","sponsor":"Swiss Cancer Institute","startDate":"2014-07-16","conditions":"Metastatic Breast Cancer, Metastatic Prostate Cancer, Bone Metastases","enrollment":1380},{"nctId":"NCT07281586","phase":"PHASE4","title":"Step-down Therapy After Long-term Osteoporosis Treatment","status":"RECRUITING","sponsor":"National Taiwan University Hospital","startDate":"2026-01-01","conditions":"Osteoporosis","enrollment":44},{"nctId":"NCT04549207","phase":"PHASE4","title":"Comparing Continuation or De-escalation of Bone Modifying Agents (BMA) in Patients Treated for Over 2 Years for Bone Metastases From Either Breast or Castration-resistant Prostate Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Ottawa Hospital Research Institute","startDate":"2020-10-09","conditions":"Breast Cancer, Castration-resistant Prostate Cancer","enrollment":240},{"nctId":"NCT02677246","phase":"PHASE1","title":"Denosumab for Prevention of Bone Complications After Bone Marrow Transplantation in Children","status":"WITHDRAWN","sponsor":"St. Justine's Hospital","startDate":"2016-12","conditions":"Disorder Related to Bone Marrow Transplantation","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Denosumab De-escalation","genericName":"Denosumab De-escalation","companyName":"National Taiwan University Hospital","companyId":"national-taiwan-university-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Denosumab de-escalation is a treatment strategy that reduces the dose or frequency of denosumab (a RANKL inhibitor) to minimize long-term adverse effects while maintaining therapeutic benefit in bone disease. Used for Osteoporosis management with reduced dosing, Bone metastases with de-escalated dosing to reduce adverse effects.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}