{"id":"prolia-denosumab","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Musculoskeletal pain"},{"rate":"10-20%","effect":"Fatigue"},{"rate":"5-10%","effect":"Back pain"},{"rate":"5-10%","effect":"Headache"},{"rate":"5-10%","effect":"Influenza"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"By binding to RANKL, denosumab inhibits the formation and activation of osteoclasts, leading to a decrease in bone resorption and an increase in bone density. This mechanism of action is particularly useful in the treatment of osteoporosis and other bone-related disorders.","oneSentence":"Prolia works by binding to RANKL, a protein involved in the formation and activation of osteoclasts, which are cells that break down bone.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:30:25.173Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Treatment of osteoporosis in postmenopausal women"},{"name":"Treatment of bone loss in patients with hormone ablation for prostate cancer"},{"name":"Treatment of bone loss in patients with hormone receptor-positive breast cancer"},{"name":"Treatment of giant cell tumor of bone"},{"name":"Treatment of osteogenesis imperfecta"}]},"trialDetails":[{"nctId":"NCT06588153","phase":"PHASE4","title":"A Study for the Evaluation of Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China","status":"RECRUITING","sponsor":"Amgen","startDate":"2025-05-24","conditions":"Glucocorticoid-induced Osteoporosis","enrollment":100},{"nctId":"NCT05405725","phase":"PHASE3","title":"A Phase 3 Study to Compare Biosimilar Denosumab With Prolia®","status":"COMPLETED","sponsor":"Enzene Biosciences Ltd.","startDate":"2022-07-04","conditions":"Postmenopausal Osteoporosis","enrollment":504},{"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":"NCT05245669","phase":"PHASE1","title":"Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers","status":"COMPLETED","sponsor":"Enzene Biosciences Ltd.","startDate":"2022-01-10","conditions":"Healthy Male Subjects","enrollment":207},{"nctId":"NCT04586660","phase":"PHASE4","title":"Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone","status":"ACTIVE_NOT_RECRUITING","sponsor":"Amgen","startDate":"2023-08-17","conditions":"Giant Cell Tumor of Bone","enrollment":36},{"nctId":"NCT05345691","phase":"PHASE3","title":"Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis","status":"COMPLETED","sponsor":"Biocon Biologics UK Ltd","startDate":"2022-05-24","conditions":"Postmenopausal Women With Osteoporosis","enrollment":479},{"nctId":"NCT05630768","phase":"PHASE4","title":"Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women","status":"COMPLETED","sponsor":"Dong-A ST Co., Ltd.","startDate":"2023-01-03","conditions":"Postmenopausal Osteoporosis","enrollment":149},{"nctId":"NCT06310824","phase":"PHASE1","title":"Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia®","status":"COMPLETED","sponsor":"Xentria, Inc.","startDate":"2024-06-05","conditions":"Healthy Participants","enrollment":225},{"nctId":"NCT07062978","phase":"PHASE3","title":"A Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia®","status":"RECRUITING","sponsor":"Qilu Pharmaceutical Co., Ltd.","startDate":"2025-06-27","conditions":"Postmenopausal Women With Osteoporosis at High Risk of Fracture","enrollment":278},{"nctId":"NCT05395091","phase":"PHASE3","title":"Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND","status":"COMPLETED","sponsor":"Alvotech Swiss AG","startDate":"2022-08-23","conditions":"Osteoporosis, Postmenopausal","enrollment":532},{"nctId":"NCT05876949","phase":"PHASE1","title":"AVT03 With Xgeva in Healthy Male Subjects","status":"COMPLETED","sponsor":"Alvotech Swiss AG","startDate":"2023-07-21","conditions":"This is a Phase I Study Conducted in Healthy Volunteers","enrollment":208},{"nctId":"NCT06504966","phase":"PHASE3","title":"Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia®","status":"WITHDRAWN","sponsor":"Xentria, Inc.","startDate":"2025-10","conditions":"Osteoporosis","enrollment":""},{"nctId":"NCT05338086","phase":"PHASE3","title":"A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis.","status":"COMPLETED","sponsor":"mAbxience Research S.L.","startDate":"2022-03-16","conditions":"Postmenopausal Women With Osteoporosis","enrollment":558},{"nctId":"NCT04907851","phase":"PHASE2","title":"A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2)","status":"COMPLETED","sponsor":"Redx Pharma Ltd","startDate":"2021-12-10","conditions":"Advanced Solid Tumours","enrollment":45},{"nctId":"NCT04934072","phase":"PHASE3","title":"A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis","status":"COMPLETED","sponsor":"Fresenius Kabi SwissBioSim GmbH","startDate":"2021-06-16","conditions":"Postmenopausal Osteoporosis","enrollment":553},{"nctId":"NCT04591275","phase":"PHASE3","title":"Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® .","status":"COMPLETED","sponsor":"Shanghai Biomabs Pharmaceutical Co., Ltd.","startDate":"2021-03-31","conditions":"Postmenopausal Osteoporosis","enrollment":278},{"nctId":"NCT03669523","phase":"PHASE2","title":"Denosumab and Nivolumab Combination As 2d-line Therapy in Stage IV NSC Lung Cancer with Bone Metastases (DENIVOS)","status":"COMPLETED","sponsor":"Centre Hospitalier Annecy Genevois","startDate":"2018-11-06","conditions":"Carcinoma, Non-Small-Cell Lung, Bone Metastases","enrollment":82},{"nctId":"NCT04664959","phase":"PHASE3","title":"A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis","status":"COMPLETED","sponsor":"Samsung Bioepis Co., Ltd.","startDate":"2020-11-26","conditions":"Postmenopausal Osteoporosis","enrollment":457},{"nctId":"NCT06804590","phase":"PHASE3","title":"A Study on Efficacy, Safety and Immunogenicity of 9MW0311 in Postmenopausal Women With Osteoporosis","status":"RECRUITING","sponsor":"Mabwell (Shanghai) Bioscience Co., Ltd.","startDate":"2024-11-16","conditions":"Postmenopausal Women Osteoporosis","enrollment":278},{"nctId":"NCT04534582","phase":"PHASE1","title":"Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects","status":"COMPLETED","sponsor":"Shanghai Henlius Biotech","startDate":"2020-11-03","conditions":"Healthy Male Volunteers","enrollment":252},{"nctId":"NCT05299073","phase":"PHASE1","title":"A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva","status":"COMPLETED","sponsor":"mAbxience Research S.L.","startDate":"2022-03-01","conditions":"Healthy Volunteers","enrollment":257},{"nctId":"NCT02150850","phase":"","title":"Quebec Registry for Atypical Femur Fractures","status":"RECRUITING","sponsor":"McGill University","startDate":"2012-04","conditions":"Atypical Femur Fracture","enrollment":150},{"nctId":"NCT02520362","phase":"","title":"Denosumab Safety Assessment in Multiple Observational Databases","status":"COMPLETED","sponsor":"Amgen","startDate":"2010-05-31","conditions":"Osteoporosis","enrollment":517991},{"nctId":"NCT05087030","phase":"PHASE3","title":"Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis","status":"COMPLETED","sponsor":"Gedeon Richter Plc.","startDate":"2021-09-21","conditions":"Postmenopausal Osteoporosis","enrollment":473},{"nctId":"NCT05352516","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture","status":"COMPLETED","sponsor":"Shanghai Henlius Biotech","startDate":"2022-06-17","conditions":"Postmenopausal","enrollment":514},{"nctId":"NCT01575834","phase":"PHASE3","title":"Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis","status":"COMPLETED","sponsor":"Amgen","startDate":"2012-03-15","conditions":"Postmenopausal Osteoporosis","enrollment":7180},{"nctId":"NCT03457818","phase":"PHASE2","title":"Therapy of the Skeletal Disease of Type 2 Diabetes With Denosumab","status":"TERMINATED","sponsor":"Mishaela Rubin","startDate":"2018-11-07","conditions":"Diabetes Mellitus, Type 2, Osteoporosis","enrollment":8},{"nctId":"NCT05126784","phase":"PHASE1","title":"AVT03 With Prolia in Healthy Male Subjects","status":"COMPLETED","sponsor":"Alvotech Swiss AG","startDate":"2022-06-29","conditions":"Healthy Male Subjects","enrollment":209},{"nctId":"NCT03401060","phase":"PHASE3","title":"Interest of Denosumab Treatment in Osteoporosis Associated to Systemic Mastocytosis","status":"COMPLETED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2018-03-05","conditions":"Osteoporosis, Systemic Mastocytosis","enrollment":24},{"nctId":"NCT04729621","phase":"PHASE3","title":"A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2021-03-22","conditions":"Osteoporosis, Postmenopausal","enrollment":332},{"nctId":"NCT05323708","phase":"PHASE1","title":"Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS","status":"COMPLETED","sponsor":"Biocon Biologics UK Ltd","startDate":"2022-03-09","conditions":"Healthy Volunteers","enrollment":190},{"nctId":"NCT05808673","phase":"PHASE1","title":"Study of CMAB807X Pre- and Post-change in Manufacturing Site and Xgeva® in Healthy Volunteers","status":"WITHDRAWN","sponsor":"Taizhou Mabtech Pharmaceutical Co.,Ltd","startDate":"2023-02","conditions":"Healthy Volunteers","enrollment":""},{"nctId":"NCT06314698","phase":"PHASE3","title":"Narlumosbart Compared With Denosumab in Patients With Multiple Myeloma Bone Disease","status":"NOT_YET_RECRUITING","sponsor":"RenJi Hospital","startDate":"2024-04-01","conditions":"Multiple Myeloma, Bone Diseases","enrollment":478},{"nctId":"NCT05419427","phase":"PHASE3","title":"Denosumab Biosimilar Injection in Post Menopausal Women With Osteoporosis","status":"UNKNOWN","sponsor":"Lambda Therapeutic Research Ltd.","startDate":"2021-11-11","conditions":"Osteoporosis, Postmenopausal","enrollment":552},{"nctId":"NCT05777109","phase":"PHASE1","title":"Comparing of the PK, PD, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults","status":"UNKNOWN","sponsor":"Jiangsu Hansoh Pharmaceutical Co., Ltd.","startDate":"2023-04-20","conditions":"Healthy","enrollment":180},{"nctId":"NCT00556374","phase":"PHASE3","title":"Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy","status":"COMPLETED","sponsor":"Amgen","startDate":"2006-12-18","conditions":"Breast Cancer","enrollment":3420},{"nctId":"NCT03974100","phase":"PHASE3","title":"Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis","status":"COMPLETED","sponsor":"Sandoz","startDate":"2019-07-02","conditions":"Postmenopausal Women With Osteoporosis","enrollment":527},{"nctId":"NCT04812509","phase":"PHASE3","title":"Efficacy and Safety of MW032 and Xgeva® in Subjects With Bone Metastases From Solid Tumors","status":"COMPLETED","sponsor":"Mabwell (Shanghai) Bioscience Co., Ltd.","startDate":"2020-03-20","conditions":"Bone Metastases","enrollment":708},{"nctId":"NCT05372224","phase":"NA","title":"Effect of Vitamin D and Denosumab on Bone Remodelling in Women With Postmenopausal Osteoporosis","status":"COMPLETED","sponsor":"Hospital Regional 1o de Octubre","startDate":"2020-06-22","conditions":"Hypovitaminosis D, Osteoporosis, Postmenopausal, Menopause","enrollment":55},{"nctId":"NCT02732210","phase":"","title":"Persistence With Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis","status":"COMPLETED","sponsor":"Amgen","startDate":"2011-07-06","conditions":"Osteoporosis, Age-Related","enrollment":935},{"nctId":"NCT04621318","phase":"PHASE1","title":"Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects","status":"COMPLETED","sponsor":"Samsung Bioepis Co., Ltd.","startDate":"2020-10-19","conditions":"Healthy","enrollment":168},{"nctId":"NCT02347865","phase":"","title":"Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France","status":"COMPLETED","sponsor":"Amgen","startDate":"2015-06-16","conditions":"Post Menopausal Osteoporosis","enrollment":777},{"nctId":"NCT00396279","phase":"PHASE2","title":"Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone","status":"COMPLETED","sponsor":"Amgen","startDate":"2006-07-10","conditions":"GCT, Giant Cell Tumor of Bone","enrollment":37},{"nctId":"NCT01345019","phase":"PHASE3","title":"Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma","status":"COMPLETED","sponsor":"Amgen","startDate":"2012-05-17","conditions":"Cancer, Hematologic Malignancies, Multiple Myeloma","enrollment":1718},{"nctId":"NCT00089791","phase":"PHASE3","title":"A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis","status":"COMPLETED","sponsor":"Amgen","startDate":"2004-08-01","conditions":"Osteoporosis","enrollment":7808},{"nctId":"NCT00321464","phase":"PHASE3","title":"A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.","status":"COMPLETED","sponsor":"Amgen","startDate":"2006-04-01","conditions":"Bone Metastases","enrollment":2049},{"nctId":"NCT00896532","phase":"PHASE2","title":"Romosozumab (AMG 785) in Postmenopausal Women With Low Bone Mineral Density","status":"COMPLETED","sponsor":"Amgen","startDate":"2009-06-03","conditions":"Low Bone Mineral Density, Postmenopausal Osteoporosis","enrollment":419},{"nctId":"NCT01077154","phase":"PHASE3","title":"Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)","status":"TERMINATED","sponsor":"Amgen","startDate":"2010-06-02","conditions":"Breast Cancer","enrollment":4509},{"nctId":"NCT03755193","phase":"PHASE2","title":"Examination of Efficacy and Safety of Other Anti-Resorption Drugs After 2-year-Denosumab Therapy in Japanese Osteoporosis Patients","status":"RECRUITING","sponsor":"Shinshu University","startDate":"2018-11-24","conditions":"Osteoporosis","enrollment":90},{"nctId":"NCT03702140","phase":"PHASE2","title":"Examination How the Administration Period of Teriparatide Affects Bone Metabolism and Bone Mineral Density Prior to Denosumab Therapy","status":"UNKNOWN","sponsor":"Shinshu University","startDate":"2018-10-09","conditions":"Osteoporosis","enrollment":90},{"nctId":"NCT04940845","phase":"PHASE1","title":"Comparing of the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults","status":"UNKNOWN","sponsor":"Shanghai Hansoh Biomedical Co., Ltd","startDate":"2021-07-26","conditions":"Postmenopausal Osteoporosis","enrollment":174},{"nctId":"NCT04859569","phase":"PHASE3","title":"Efficacy and Safety of LY01011 and Xgeva® in Patients With Bone Metastases From Solid Tumors","status":"UNKNOWN","sponsor":"Luye Pharma Group Ltd.","startDate":"2021-04-30","conditions":"Bone Metastases From Solid Tumors","enrollment":850},{"nctId":"NCT04798313","phase":"PHASE1","title":"Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW031 and Prolia® in Healthy Adults","status":"COMPLETED","sponsor":"Mabwell (Shanghai) Bioscience Co., Ltd.","startDate":"2020-06-02","conditions":"Osteoporosis, Postmenopausal","enrollment":120},{"nctId":"NCT04798326","phase":"PHASE1","title":"Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW032 and Xgeva® in Healthy Adults","status":"COMPLETED","sponsor":"Mabwell (Shanghai) Bioscience Co., Ltd.","startDate":"2019-06-25","conditions":"Bone Tumor","enrollment":120},{"nctId":"NCT04673799","phase":"PHASE1","title":"Comparing of the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults.","status":"UNKNOWN","sponsor":"Kunming Pharmaceuticals, Inc.","startDate":"2021-02-22","conditions":"Healthy","enrollment":144},{"nctId":"NCT03925051","phase":"PHASE1","title":"Phase 1 Study to Compare CMAB807 Injection to Prolia® in Healthy Volunteers","status":"COMPLETED","sponsor":"Shanghai Biomabs Pharmaceutical Co., Ltd.","startDate":"2019-07-01","conditions":"Postmenopausal Osteoporosis","enrollment":132},{"nctId":"NCT04550949","phase":"PHASE3","title":"To Evaluate the Efficacy and Safety of QL1206 and Xgeva in Patients With Bone Metastases From Solid Tumors","status":"UNKNOWN","sponsor":"Qilu Pharmaceutical Co., Ltd.","startDate":"2019-04-26","conditions":"Bone Metastases","enrollment":700},{"nctId":"NCT04494373","phase":"PHASE1","title":"Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults","status":"UNKNOWN","sponsor":"Jiangsu Hansoh Pharmaceutical Co., Ltd.","startDate":"2020-09-01","conditions":"Bone Metastasis From Solid Tumors","enrollment":154},{"nctId":"NCT00919711","phase":"PHASE3","title":"Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate Therapy","status":"COMPLETED","sponsor":"Amgen","startDate":"2009-09-01","conditions":"Osteoporosis","enrollment":870},{"nctId":"NCT03293108","phase":"PHASE3","title":"Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Denosumab 60 mg (Arylia) Versus Prolia® in Improvement of Bone Mineral Densitometry (BMD) Among Osteoporotic Postmenopausal Women","status":"UNKNOWN","sponsor":"AryoGen Pharmed Co.","startDate":"2017-04-29","conditions":"Osteoporosis","enrollment":190},{"nctId":"NCT01732770","phase":"PHASE4","title":"Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis","status":"COMPLETED","sponsor":"Amgen","startDate":"2012-11-07","conditions":"Post Menopausal Osteoporosis","enrollment":643},{"nctId":"NCT01545648","phase":"PHASE2","title":"Pilot Study to Evaluate the Impact of Denosumab on Disseminated Tumor Cells (DTC) in Patients With Early Stage Breast Cancer","status":"TERMINATED","sponsor":"Hope Rugo, MD","startDate":"2012-11-01","conditions":"Early Stage Breast Cancer","enrollment":4},{"nctId":"NCT04213105","phase":"PHASE1","title":"Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Prolia® in Healthy Adults","status":"UNKNOWN","sponsor":"Qilu Pharmaceutical Co., Ltd.","startDate":"2019-10-31","conditions":"Healthy People","enrollment":144},{"nctId":"NCT04198636","phase":"PHASE1","title":"A Study to Evaluate LY01011 and Xgeva® in Healthy Adults","status":"UNKNOWN","sponsor":"Luye Pharma Group Ltd.","startDate":"2019-12-16","conditions":"Healthy Adults","enrollment":168},{"nctId":"NCT03651947","phase":"PHASE1","title":"Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Xgeva® in Healthy Adults","status":"COMPLETED","sponsor":"Qilu Pharmaceutical Co., Ltd.","startDate":"2018-08-20","conditions":"Healthy People","enrollment":168},{"nctId":"NCT01652690","phase":"","title":"Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice","status":"COMPLETED","sponsor":"Amgen","startDate":"2012-06-26","conditions":"Osteoporosis, Postmenopausal","enrollment":600},{"nctId":"NCT00286091","phase":"PHASE3","title":"Study on Prolonging Bone Metastasis-Free Survival in Men With Hormone Refractory Prostate Cancer","status":"COMPLETED","sponsor":"Amgen","startDate":"2006-01-24","conditions":"Hormone Refractory Prostate Cancer","enrollment":1435},{"nctId":"NCT00321620","phase":"PHASE3","title":"Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer","status":"COMPLETED","sponsor":"Amgen","startDate":"2006-04-01","conditions":"Bone Metastases","enrollment":1904},{"nctId":"NCT01575873","phase":"PHASE3","title":"Efficacy and Safety of Denosumab Compared With Risedronate in Individuals Taking Glucocorticoids","status":"COMPLETED","sponsor":"Amgen","startDate":"2012-03-28","conditions":"Steroid-induced Osteopor, Glucocorticoid-induced Ostepor","enrollment":795},{"nctId":"NCT00926380","phase":"PHASE2","title":"Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2009-06","conditions":"Osteoporosis","enrollment":94},{"nctId":"NCT01668589","phase":"","title":"Observational Study of Denosumab (Prolia®) in Postmenopausal Women With Osteoporosis","status":"COMPLETED","sponsor":"Amgen","startDate":"2011-11-28","conditions":"Postmenopausal Osteoporosis","enrollment":1501},{"nctId":"NCT01998607","phase":"","title":"Survey of XGEVA® Presrcibers in Europe to Evaluate Their Knowledge of the Summary of Product Characteristics Pertaining to Osteonecrosis of the Jaw","status":"COMPLETED","sponsor":"Amgen","startDate":"2013-02-04","conditions":"Solid Tumours, Bone Metastasis","enrollment":420},{"nctId":"NCT02053753","phase":"PHASE1","title":"Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product","status":"COMPLETED","sponsor":"Amgen","startDate":"2014-02","conditions":"Healthy Volunteer","enrollment":146},{"nctId":"NCT02157948","phase":"PHASE3","title":"A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis","status":"COMPLETED","sponsor":"Amgen","startDate":"2014-05","conditions":"Postmenopausal Osteoporosis","enrollment":394},{"nctId":"NCT01294397","phase":"PHASE1","title":"Effects of Denosumab on the Pharmacokinetics of Etanercept","status":"TERMINATED","sponsor":"Amgen","startDate":"2011-03","conditions":"Postmenopausal, Osteopenia, Rheumatoid Arthritis","enrollment":19},{"nctId":"NCT00925600","phase":"PHASE3","title":"Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss","status":"COMPLETED","sponsor":"Amgen","startDate":"2009-11-30","conditions":"Cancer, Cataract, Low Bone Mineral Density","enrollment":769},{"nctId":"NCT01750086","phase":"PHASE4","title":"Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2013-01","conditions":"Postmenopausal Osteoporosis","enrollment":27},{"nctId":"NCT02066805","phase":"","title":"Estimation of Off-Label Use of XGEVA® (Denosumab) Using Population-Based Databases in Denmark","status":"COMPLETED","sponsor":"Amgen","startDate":"2014-01","conditions":"XGEVA Off-label Use","enrollment":142},{"nctId":"NCT01824342","phase":"PHASE3","title":"Denosumab for Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer","status":"COMPLETED","sponsor":"Amgen","startDate":"2011-01","conditions":"Castrate-resistant Prostate Cancer","enrollment":18},{"nctId":"NCT01770106","phase":"PHASE4","title":"RA Denosumab on Bone Microstructure Study","status":"COMPLETED","sponsor":"Chinese University of Hong Kong","startDate":"2012-12","conditions":"Rheumatoid Arthritis","enrollment":40}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Prolia® (Denosumab)","genericName":"Prolia® (Denosumab)","companyName":"Samsung Bioepis Co., Ltd.","companyId":"samsung-bioepis-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Prolia works by binding to RANKL, a protein involved in the formation and activation of osteoclasts, which are cells that break down bone. Used for Treatment of osteoporosis in postmenopausal women, Treatment of bone loss in patients with hormone ablation for prostate cancer, Treatment of bone loss in patients with hormone receptor-positive breast cancer.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}