{"id":"placebo-to-zoledronic-acid","safety":{"commonSideEffects":[{"rate":null,"effect":"Osteonecrosis of the jaw"},{"rate":null,"effect":"Atypical femoral fractures"},{"rate":null,"effect":"Renal impairment"},{"rate":null,"effect":"Hypocalcemia"},{"rate":"20-30","effect":"Fever and flu-like symptoms"},{"rate":"10-20","effect":"Arthralgia/myalgia"}]},"_chembl":{"chemblId":"CHEMBL4303669","moleculeType":"Small molecule","molecularWeight":"290.11"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Zoledronic acid works by reducing osteoclast activity and promoting osteoclast apoptosis, thereby decreasing bone turnover and resorption. It is used to treat conditions characterized by excessive bone loss or abnormal bone metabolism, including osteoporosis, hypercalcemia of malignancy, and bone metastases. The drug strengthens bone density and reduces fracture risk by shifting the balance toward bone formation.","oneSentence":"Zoledronic acid is a bisphosphonate that inhibits osteoclast-mediated bone resorption by binding to hydroxyapatite in bone and blocking farnesyl pyrophosphate synthase in the mevalonate pathway.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:01:29.579Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypercalcemia of malignancy"},{"name":"Multiple myeloma with bone disease"},{"name":"Bone metastases from solid tumors"},{"name":"Osteoporosis prevention and treatment"}]},"trialDetails":[{"nctId":"NCT06533865","phase":"PHASE3","title":"Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea","status":"RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2025-03-19","conditions":"FHA (Functional Hypothalamic Amenorrhea)","enrollment":114},{"nctId":"NCT04608630","phase":"PHASE2","title":"Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults","status":"RECRUITING","sponsor":"Australian and New Zealand Intensive Care Research Centre","startDate":"2021-07-15","conditions":"Critical Illness, Osteoporosis","enrollment":450},{"nctId":"NCT05058976","phase":"PHASE4","title":"Romosozumab Use to Build Skeletal Integrity","status":"ACTIVE_NOT_RECRUITING","sponsor":"Susan L. Greenspan","startDate":"2021-09-15","conditions":"Osteoporosis, Osteoporosis, Postmenopausal, Osteoporosis Fracture","enrollment":184},{"nctId":"NCT06118905","phase":"PHASE4","title":"Preserving Geriatric Muscle With an Osteoporosis Medication","status":"RECRUITING","sponsor":"Susan L. Greenspan","startDate":"2024-02-08","conditions":"Osteoporosis","enrollment":155},{"nctId":"NCT02325414","phase":"PHASE2","title":"Prevention of Bone Loss After Acute SCI by Zoledronic Acid","status":"COMPLETED","sponsor":"Northwestern University","startDate":"2015-02","conditions":"Spinal Cord Injury, Acute Spinal Cord Injury, Bone Loss","enrollment":60},{"nctId":"NCT04087096","phase":"PHASE4","title":"Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2020-08-24","conditions":"Bariatric Surgery Candidate, Bone Loss","enrollment":36},{"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":"NCT07056478","phase":"PHASE3","title":"RANKL Inhibition to Combat Sarcopenia in Hip Fracture Patients","status":"NOT_YET_RECRUITING","sponsor":"Prince of Wales Hospital, Shatin, Hong Kong","startDate":"2026-01-01","conditions":"Sarcopenia in Elderly","enrollment":130},{"nctId":"NCT06859580","phase":"PHASE4","title":"Bisphosphonate Prior to Parathyroidectomy in Primary Hyperparathyroidism","status":"RECRUITING","sponsor":"University of Aarhus","startDate":"2025-03-01","conditions":"Primary Hyperparathyroidism","enrollment":140},{"nctId":"NCT06643780","phase":"PHASE4","title":"RANK-ligand Inhibition to Combat Sarcopenia with Underlying Osteoporosis","status":"RECRUITING","sponsor":"Prince of Wales Hospital, Shatin, Hong Kong","startDate":"2024-04-09","conditions":"Sarcopenia in Elderly","enrollment":120},{"nctId":"NCT01348269","phase":"PHASE3","title":"Assessment of Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome","status":"COMPLETED","sponsor":"Wuerzburg University Hospital","startDate":"2011-05","conditions":"Bone Marrow Edema","enrollment":48},{"nctId":"NCT05025293","phase":"PHASE4","title":"Zoledronate Early to Hip Fracture Patients - Safe and Effective?","status":"RECRUITING","sponsor":"Lene Bergendal Solberg","startDate":"2021-12-15","conditions":"Hip Fractures, Osteoporosis","enrollment":300},{"nctId":"NCT06221072","phase":"PHASE3","title":"A Study to Assess the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors Treated With JMT103 Compared to Zoledronic Acid","status":"NOT_YET_RECRUITING","sponsor":"Shanghai JMT-Bio Inc.","startDate":"2024-04-05","conditions":"Imaging Examination Shows at Least One Site With Bone Metastases From Soild Tumors","enrollment":1360},{"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":"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":"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":"NCT00330759","phase":"PHASE3","title":"Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.","status":"COMPLETED","sponsor":"Amgen","startDate":"2006-06-01","conditions":"Bone Metastases","enrollment":1779},{"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":"NCT04742010","phase":"PHASE2","title":"Zoledronic Acid for Prevention of Bone Loss After BAriatric Surgery (ZABAS)","status":"UNKNOWN","sponsor":"Stinus Gadegaard Hansen","startDate":"2021-02-20","conditions":"Bone Loss, Muscle Atrophy, Bariatric Surgery","enrollment":60},{"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":"NCT04719650","phase":"PHASE4","title":"Clinical Pharmacokinetics and Pharmacodynamics Study of Different Doses of Zoledronic Acid","status":"UNKNOWN","sponsor":"Peking University Third Hospital","startDate":"2021-10","conditions":"Postmenopausal Osteoporosis","enrollment":64},{"nctId":"NCT00799266","phase":"PHASE3","title":"An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2008-12-04","conditions":"Osteoporosis","enrollment":34},{"nctId":"NCT00079001","phase":"PHASE3","title":"Zoledronate in Preventing Skeletal (Bone)-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases","status":"COMPLETED","sponsor":"Alliance for Clinical Trials in Oncology","startDate":"2004-01","conditions":"Metastatic Cancer, Prostate Cancer","enrollment":645},{"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":"NCT04115397","phase":"PHASE4","title":"Bisphosphonates for the Treatment of Seropositive Musculoskeletal Complaints","status":"UNKNOWN","sponsor":"Karolinska Institutet","startDate":"2020-01","conditions":"Seropositive Muskuloskeletal Complaints","enrollment":80},{"nctId":"NCT03576599","phase":"PHASE4","title":"Intravenous Bisphosphonate in Stress Fracture Treatment -A Randomised Controlled Double Blinded Multicenter Trial","status":"TERMINATED","sponsor":"Oslo University Hospital","startDate":"2017-06-29","conditions":"Stress Fracture Foot, Stress Fracture Ankle","enrollment":5},{"nctId":"NCT02746068","phase":"PHASE3","title":"A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions","status":"UNKNOWN","sponsor":"Axsome Therapeutics, Inc.","startDate":"2016-03","conditions":"Osteoarthritis, Knee","enrollment":346},{"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":"NCT00399802","phase":"PHASE2","title":"A Study to Examine the Effects of an Experimental Drug on Women With Breast Cancer and Metastatic Bone Disease (MBD)(0822-016)(COMPLETED)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2006-11-16","conditions":"Breast Cancer, Metastatic Bone Disease","enrollment":43},{"nctId":"NCT01228318","phase":"PHASE2","title":"Bone Loss and Immune Reconstitution in HIV/AIDS (BLIR-HIV)","status":"COMPLETED","sponsor":"Emory University","startDate":"2011-01","conditions":"HIV Infection, Bone Loss, Osteopenia","enrollment":63},{"nctId":"NCT02504008","phase":"PHASE3","title":"CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1","status":"UNKNOWN","sponsor":"Axsome Therapeutics, Inc.","startDate":"2015-07","conditions":"Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy","enrollment":190},{"nctId":"NCT00278434","phase":"PHASE1","title":"Zoledronate in Treating Patients With Cervical Intraepithelial Neoplasia 2/3 or 3","status":"TERMINATED","sponsor":"University of California, San Francisco","startDate":"2005-04","conditions":"Cervical Cancer, Precancerous Condition","enrollment":12},{"nctId":"NCT00063609","phase":"PHASE4","title":"The Effect of Zoledronic Acid on Bone Loss in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2003-04","conditions":"Prostate Cancer","enrollment":200},{"nctId":"NCT00099203","phase":"PHASE3","title":"A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease","status":"TERMINATED","sponsor":"Hoffmann-La Roche","startDate":"2005-07","conditions":"Pain, Bone Neoplasm, Neoplasm Metastasis","enrollment":163},{"nctId":"NCT02451462","phase":"NA","title":"Pilot Trial of Zoledronic Acid to Prevent Bone Loss in Hematopoietic Cell Transplant Recipients","status":"WITHDRAWN","sponsor":"Stanford University","startDate":"2015-09","conditions":"Hematopoietic Stem Cell Transplant, Bone Marrow Transplant","enrollment":""},{"nctId":"NCT01907880","phase":"PHASE4","title":"The ODYSSEY TRIAL Phase IV Trial Evaluating the Palliative Benefit of Pamidronate or Zoledronic Acid in Breast Cancer","status":"COMPLETED","sponsor":"Ottawa Hospital Research Institute","startDate":"2012-08","conditions":"Breast Cancer","enrollment":74},{"nctId":"NCT00439647","phase":"PHASE3","title":"Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2006-12","conditions":"Male Osteoporosis","enrollment":1199},{"nctId":"NCT01218035","phase":"PHASE4","title":"Efficacy of Zoledronic Acid in Enhancement of Early Stability of Cementless Primary Hip Prosthesis","status":"COMPLETED","sponsor":"Turku University Hospital","startDate":"2007-05","conditions":"Hip Osteoarthritis","enrollment":49},{"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":"NCT00132808","phase":"PHASE3","title":"Zoledronic Acid in the Prevention of Bone Loss in Postmenopausal Women With Osteopenia, 45 Years of Age and Older","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2004-07","conditions":"Osteopenia","enrollment":581},{"nctId":"NCT01702415","phase":"PHASE4","title":"Zoledronic Acid in Cystic Fibrosis","status":"WITHDRAWN","sponsor":"Papworth Hospital NHS Foundation Trust","startDate":"2013-10","conditions":"Cystic Fibrosis","enrollment":""},{"nctId":"NCT00718861","phase":"PHASE3","title":"3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2008-05","conditions":"Post-menopausal Osteoporosis","enrollment":190},{"nctId":"NCT00320710","phase":"PHASE3","title":"Continued Efficacy and Safety of Zoledronic Acid (q 4 Wks vs. q 12 Wks) in the 2nd Year of Treatment in Patients With Bone Metastases From Breast Cancer","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2006-02","conditions":"Breast Cancer","enrollment":416},{"nctId":"NCT00050011","phase":"PHASE3","title":"Zoledronic Acid - Letrozole Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal Therapy","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2002-09","conditions":"Breast Neoplasms, Osteoporosis","enrollment":602},{"nctId":"NCT01330238","phase":"PHASE2","title":"The Efficacy of Zoledronic Acid in Modic Changes-related Low Back Pain (LBP)","status":"COMPLETED","sponsor":"University of Oulu","startDate":"2008-12","conditions":"Low Back Pain","enrollment":40},{"nctId":"NCT01166178","phase":"PHASE3","title":"Zoledronic Acid in MS-patients With Osteoporosis","status":"TERMINATED","sponsor":"Novartis","startDate":"2010-10","conditions":"Osteoporosis, Multiple Sclerosis","enrollment":29},{"nctId":"NCT00181584","phase":"PHASE2","title":"Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2003-09","conditions":"Bone Loss, Prostate Cancer","enrollment":60},{"nctId":"NCT00005073","phase":"PHASE3","title":"Zoledronate Plus Standard Therapy Compared With Placebo Plus Standard Therapy to Prevent Bone Metastases in Patients With Recurrent Prostate Cancer That Has No Symptoms","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"1999-09","conditions":"Prostate Cancer","enrollment":544},{"nctId":"NCT00927186","phase":"PHASE4","title":"Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2009-07","conditions":"Osteoporosis, Post-menopausal","enrollment":69},{"nctId":"NCT00003884","phase":"PHASE3","title":"Zoledronate in Treating Patients With Solid Tumors That Have Spread to the Bone","status":"COMPLETED","sponsor":"Novartis","startDate":"1998-08","conditions":"Hypercalcemia of Malignancy, Lung Cancer, Metastatic Cancer","enrollment":600},{"nctId":"NCT00741377","phase":"PHASE1","title":"A Study to Assess BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2009-01","conditions":"Multiple Myeloma Bone Disease","enrollment":28},{"nctId":"NCT01788176","phase":"PHASE2","title":"The Use of Zoledronic Acid to Complex Regional Pain Syndrome","status":"UNKNOWN","sponsor":"University of Sao Paulo General Hospital","startDate":"2013-12","conditions":"Complex Regional Pain Syndromes","enrollment":40},{"nctId":"NCT00103740","phase":"PHASE3","title":"Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2002-04","conditions":"Paget's Disease of Bone","enrollment":185},{"nctId":"NCT00051636","phase":"PHASE3","title":"Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2001-01","conditions":"Paget's Disease of Bone","enrollment":172},{"nctId":"NCT00145327","phase":"PHASE3","title":"Double-blind Extension of HORIZON Pivotal Fracture Trial (Zoledronic Acid in the Treatment of Postmenopausal Osteoporosis)","status":"COMPLETED","sponsor":"Novartis","startDate":"2005-05","conditions":"Osteoporosis","enrollment":2456},{"nctId":"NCT00439244","phase":"PHASE3","title":"Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis","status":"COMPLETED","sponsor":"Novartis","startDate":"2006-12","conditions":"Osteoporosis","enrollment":412},{"nctId":"NCT00431444","phase":"PHASE4","title":"Effects of Zoledronic Acid and Raloxifene on Bone Turnover Markers in Postmenopausal Women With Low Bone Mineral Density","status":"COMPLETED","sponsor":"Novartis","startDate":"2007-01","conditions":"Osteoporosis","enrollment":110},{"nctId":"NCT01310465","phase":"PHASE4","title":"The Effect of Zoledronic Acid to Bone Fusion and Bone Metabolism of Patients With Lumbar Degenerative Disease After Lumbar Interbody Fusion","status":"UNKNOWN","sponsor":"Fudan University","startDate":"2011-01","conditions":"Image Changes of Lumbar Fusion, Bone Turnover Markers, Bone Mineral Density","enrollment":50},{"nctId":"NCT00489424","phase":"PHASE4","title":"Acetaminophen or Fluvastatin Compared to Placebo on the Transient Post-Dose Symptoms (PDS) Following an Intravenous (i.v.) Infusion of a Single Dose of Zoledronic Acid 5mg, in Post-menopausal Women With Low Bone Mass","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2007-06","conditions":"Osteoporosis","enrollment":793},{"nctId":"NCT00102908","phase":"PHASE2","title":"Bisphosphonate Therapy for HIV-Infected Adults With Decreased Bone Mineral Density","status":"UNKNOWN","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2005-05","conditions":"HIV Infections, Osteopenia, Osteoporosis","enrollment":30}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":391,"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":"Placebo to zoledronic acid","genericName":"Placebo to zoledronic acid","companyName":"Amgen","companyId":"amgen","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Zoledronic acid is a bisphosphonate that inhibits osteoclast-mediated bone resorption by binding to hydroxyapatite in bone and blocking farnesyl pyrophosphate synthase in the mevalonate pathway. Used for Hypercalcemia of malignancy, Multiple myeloma with bone disease, Bone metastases from solid tumors.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}