{"id":"placebo-for-denosumab","safety":{"commonSideEffects":[]},"_chembl":{"chemblId":"CHEMBL1237023","moleculeType":"Antibody"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Placebo is an inactive substance used in randomized controlled trials to establish baseline efficacy and safety of an active drug (in this case, denosumab) through comparison against a non-therapeutic control. It allows researchers to distinguish true drug effects from natural disease progression, spontaneous remission, and placebo response effects.","oneSentence":"Placebo has no active pharmacological mechanism and serves as an inert control comparator in clinical trials.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:00:50.045Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Control arm in denosumab clinical trials"}]},"trialDetails":[{"nctId":"NCT06300229","phase":"PHASE1, PHASE2","title":"NAPO - Novel Approach for Oligospermia","status":"COMPLETED","sponsor":"Martin Blomberg Jensen","startDate":"2024-03-01","conditions":"Infertility, Male","enrollment":42},{"nctId":"NCT04067726","phase":"PHASE2","title":"RANKL Inhibition and Mammographic Breast Density","status":"ACTIVE_NOT_RECRUITING","sponsor":"Washington University School of Medicine","startDate":"2019-08-27","conditions":"Dense Breasts","enrollment":210},{"nctId":"NCT05655013","phase":"PHASE4","title":"Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis 2 (ZOLARMAB2)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Aarhus University Hospital","startDate":"2023-05-10","conditions":"Osteoporosis, Postmenopausal","enrollment":200},{"nctId":"NCT06524960","phase":"PHASE1, PHASE2","title":"Denosumab for Type 1 Diabetes","status":"RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2024-09-03","conditions":"Type 1 Diabetes","enrollment":45},{"nctId":"NCT04711109","phase":"PHASE3","title":"Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation","status":"ACTIVE_NOT_RECRUITING","sponsor":"Alliance for Clinical Trials in Oncology","startDate":"2023-02-14","conditions":"BRCA1 Mutation, Breast Cancer, Breast Diseases","enrollment":300},{"nctId":"NCT04232657","phase":"PHASE2","title":"Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI","status":"ACTIVE_NOT_RECRUITING","sponsor":"VA Office of Research and Development","startDate":"2021-03-01","conditions":"Spinal Cord Injury (=3 Years), Sublesional Bone Loss Secondary to SCI","enrollment":36},{"nctId":"NCT03792763","phase":"PHASE2","title":"Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients","status":"COMPLETED","sponsor":"Arbeitsgemeinschaft medikamentoese Tumortherapie","startDate":"2019-09-30","conditions":"Multiple Myeloma","enrollment":8},{"nctId":"NCT05966064","phase":"PHASE4","title":"DEnosumab for the Treatment of FIbrous Dysplasia/McCune-Albright Syndrome in Adults (DeFiD)","status":"RECRUITING","sponsor":"Natasha Appelman-Dijkstra","startDate":"2023-06-13","conditions":"Fibrous Dysplasia, McCune Albright Syndrome","enrollment":82},{"nctId":"NCT02771860","phase":"PHASE2","title":"RANKL-blockade for the Treatment of Erosive Osteoarthritis (OA) of Interphalangeal Finger Joints","status":"COMPLETED","sponsor":"University Hospital, Ghent","startDate":"2016-03","conditions":"Hand Osteoarthritis","enrollment":100},{"nctId":"NCT02753283","phase":"PHASE4","title":"Preventing Osteoporosis Using Denosumab","status":"COMPLETED","sponsor":"Susan L. Greenspan","startDate":"2016-06","conditions":"Osteoporosis, Postmenopausal, Osteoporosis, Osteoporotic Fractures","enrollment":201},{"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":"NCT06154707","phase":"PHASE3","title":"Clinical Controlled Study on the Efficacy of Denosumab in Treating Osteoporosis in the Domestic Population and Its Impact on Sarcopenia-related Outcomes","status":"UNKNOWN","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","startDate":"2024-02-01","conditions":"Sarcopenia, Osteoporosis, Denosumab","enrollment":86},{"nctId":"NCT03960554","phase":"PHASE2","title":"The Effects of 12-months of Denosumab on Bone Density in Prevalent Kidney Transplant Recipients","status":"TERMINATED","sponsor":"Thomas Nickolas, MD MS","startDate":"2020-01-16","conditions":"Osteoporosis, Renal Osteodystrophy, Kidney Transplant; Complications","enrollment":8},{"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":"NCT03029442","phase":"PHASE4","title":"The Efficacy of Denosumab in Incomplete Patients Spinal Cord Injury","status":"TERMINATED","sponsor":"James J. Peters Veterans Affairs Medical Center","startDate":"2017-04-01","conditions":"Secondary Osteoporosis, Spinal Cord Injury","enrollment":5},{"nctId":"NCT02864784","phase":"PHASE1","title":"Investigating the Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC) on the Treatment of Subjects With CRPC","status":"WITHDRAWN","sponsor":"Amorphical Ltd.","startDate":"2022-06","conditions":"Castrate Resistant Prostate Cancer With Bone Metastasis","enrollment":""},{"nctId":"NCT06272227","phase":"PHASE4","title":"Effect of Alfacalcidol on Muscle Function in Osteoporosis Patients","status":"UNKNOWN","sponsor":"Yonsei University","startDate":"2024-02-13","conditions":"Sarcopenia","enrollment":340},{"nctId":"NCT02792413","phase":"PHASE4","title":"Study Evaluating Denosumab on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease","status":"TERMINATED","sponsor":"University Hospital, Montpellier","startDate":"2018-11-19","conditions":"Female With Osteoporosis and Chronic Kidney Disease","enrollment":4},{"nctId":"NCT05065164","phase":"PHASE2, PHASE3","title":"Denosumab and Screw Fixation for Osteoporotic Compression Fracture","status":"WITHDRAWN","sponsor":"Shenzhen People's Hospital","startDate":"2021-09-14","conditions":"Denosumab Allergy","enrollment":""},{"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":"NCT01558115","phase":"PHASE4","title":"Denosumab in Primary Hyperparathyroidism","status":"TERMINATED","sponsor":"Columbia University","startDate":"2012-01","conditions":"Primary Hyperparathyroidism","enrollment":8},{"nctId":"NCT05559268","phase":"PHASE4","title":"Effects of Denosumab on Bone Microarchitecture After Total Knee Arthroplasty","status":"UNKNOWN","sponsor":"The Affiliated Hospital of Qingdao University","startDate":"2022-10-01","conditions":"Osteoarthritis, Knee","enrollment":60},{"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":"NCT01358669","phase":"PHASE2","title":"Effect of Denosumab on Inflammatory Osteolytic Lesion Activity in Total Hip Arthroplasty","status":"COMPLETED","sponsor":"Sheffield Teaching Hospitals NHS Foundation Trust","startDate":"2011-12-14","conditions":"Revision Surgery of Total Hip Arthroplasty","enrollment":24},{"nctId":"NCT03520231","phase":"PHASE2","title":"Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases","status":"COMPLETED","sponsor":"University Health Network, Toronto","startDate":"2018-09-04","conditions":"Urothelial Carcinoma, Kidney Cancer, Ureter Cancer","enrollment":6},{"nctId":"NCT01951586","phase":"PHASE2","title":"Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer","status":"COMPLETED","sponsor":"Amgen","startDate":"2013-12-31","conditions":"Non-Small Cell Lung Cancer","enrollment":226},{"nctId":"NCT00095498","phase":"PHASE2","title":"Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis","status":"COMPLETED","sponsor":"Amgen","startDate":"2004-08-11","conditions":"Rheumatoid Arthritis","enrollment":227},{"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":"NCT03027557","phase":"PHASE3","title":"Treatment of Primary Hyperparathyroidism With Denosumab and Cinacalcet.","status":"COMPLETED","sponsor":"Peter Vestergaard","startDate":"2017-03-01","conditions":"Primary Hyperparathyroidism, Parathyroid Adenoma, Parathyroid Hyperplasia","enrollment":46},{"nctId":"NCT04231682","phase":"PHASE2","title":"A Study to Evaluate Efficacy and Safety of Denosumab for Prevention and Treatment of Osteoporosis in 1st Time Liver Transplant Recipients.","status":"WITHDRAWN","sponsor":"Albert Einstein Healthcare Network","startDate":"2020-07-01","conditions":"Osteoporosis","enrollment":""},{"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":"NCT02559648","phase":"PHASE2","title":"Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis","status":"COMPLETED","sponsor":"Ersi Voskaridou","startDate":"2014-09","conditions":"Thalassemia Major, Osteoporosis","enrollment":63},{"nctId":"NCT01983475","phase":"PHASE4","title":"Denosumab Administration After Spinal Cord Injury","status":"UNKNOWN","sponsor":"James J. Peters Veterans Affairs Medical Center","startDate":"2015-01","conditions":"Osteoporosis, Spinal Cord Injury","enrollment":24},{"nctId":"NCT02299817","phase":"PHASE2","title":"Denosumab for Treating Periprosthetic Osteolysis.","status":"UNKNOWN","sponsor":"Olof Skoldenberg","startDate":"2015-08","conditions":"Osteolysis","enrollment":20},{"nctId":"NCT00089661","phase":"PHASE3","title":"AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer","status":"COMPLETED","sponsor":"Amgen","startDate":"2004-10-01","conditions":"Breast Cancer, Low Bone Mineral Density, Osteopenia","enrollment":252},{"nctId":"NCT00980174","phase":"PHASE3","title":"Study to Compare the Efficacy and Safety of DenosumAb Versus Placebo in Males With Osteoporosis","status":"COMPLETED","sponsor":"Amgen","startDate":"2009-10-01","conditions":"Low Bone Mass, Low Bone Mineral Density, Males With Osteoporosis","enrollment":242},{"nctId":"NCT00089674","phase":"PHASE3","title":"AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer","status":"COMPLETED","sponsor":"Amgen","startDate":"2004-08-01","conditions":"Prostate Cancer","enrollment":1468},{"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":"NCT01926158","phase":"PHASE4","title":"Denosumab in Enhancement of Bone Bonding of Hip Prosthesis in Postmenopausal Women","status":"COMPLETED","sponsor":"Turku University Hospital","startDate":"2013-12","conditions":"Hip Osteoarthritis","enrollment":65},{"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":"NCT01630941","phase":"PHASE2","title":"Effects of Denosumab on Periprosthetic Bone After Total Hip Arthroplasty","status":"COMPLETED","sponsor":"Hans Mallmin","startDate":"2012-08-07","conditions":"Osteoarthritis, Hip, Ambulation Difficulty","enrollment":64},{"nctId":"NCT01920568","phase":"PHASE3","title":"A Study to Compare Denosumab With Zoledronic Acid in Subjects With Bone Metastases From Solid Tumors","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2013-08","conditions":"Fractures, Bone","enrollment":487},{"nctId":"NCT01734824","phase":"PHASE4","title":"Treatment of Atraumatic Bone Marrow Edema With Denosumab and Teriparatide vs Placebo","status":"SUSPENDED","sponsor":"Medical University of Vienna","startDate":"2012-05","conditions":"Bone Marrow Oedema Syndrome, High Turnover Bone Disease, Quality of Life","enrollment":90},{"nctId":"NCT00680953","phase":"PHASE3","title":"Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis","status":"COMPLETED","sponsor":"Daiichi Sankyo Co., Ltd.","startDate":"2008-05","conditions":"Osteoporosis","enrollment":1262},{"nctId":"NCT00293813","phase":"PHASE2","title":"A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density","status":"COMPLETED","sponsor":"Amgen","startDate":"2006-05","conditions":"Postmenopausal Osteoporosis","enrollment":247},{"nctId":"NCT01978483","phase":"PHASE1","title":"Effect of RANKL Inhibition on UV-induced Immunosuppression","status":"COMPLETED","sponsor":"Innovaderm Research Inc.","startDate":"2013-11","conditions":"Ultraviolet Rays, Immunosuppression, Hypersensitivity, Delayed","enrollment":31},{"nctId":"NCT00043186","phase":"PHASE2","title":"Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density","status":"COMPLETED","sponsor":"Amgen","startDate":"2002-05","conditions":"Low Bone Mineral Density","enrollment":412}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":381,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Prefilled syringe of 1 mL placebo solution"],"phase":"marketed","status":"active","brandName":"Placebo (for denosumab)","genericName":"Placebo (for denosumab)","companyName":"Turku University Hospital","companyId":"turku-university-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Placebo has no active pharmacological mechanism and serves as an inert control comparator in clinical trials. Used for Control arm in denosumab clinical trials.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}