{"id":"placebo-to-alendronate","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Abdominal pain"},{"rate":"5-10%","effect":"Dyspepsia"},{"rate":"5-10%","effect":"Back pain"},{"rate":"5-10%","effect":"Arthralgia"},{"rate":"5-10%","effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"Alendronate is a bisphosphonate that binds to hydroxyapatite in bone, inhibiting osteoclast-mediated bone resorption and leading to an increase in bone mineral density. This results in a decrease in the risk of fractures and other bone-related complications.","oneSentence":"Alendronate works by inhibiting osteoclast-mediated bone resorption.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:51:47.757Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Treatment of osteoporosis in postmenopausal women and men"},{"name":"Treatment of glucocorticoid-induced osteoporosis"}]},"trialDetails":[{"nctId":"NCT06973109","phase":"PHASE2","title":"Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes","status":"NOT_YET_RECRUITING","sponsor":"Nitin Agarwal","startDate":"2026-03-20","conditions":"Osteoporosis, Post-menopausal","enrollment":36},{"nctId":"NCT07435051","phase":"PHASE3","title":"Prospective, Randomized, Multicenter Clinical Trial of Bisphosphonates Combined With Vancomycin for the Treatment of Cierny-Mader Type I and III Osteomyelitis","status":"NOT_YET_RECRUITING","sponsor":"Second Affiliated Hospital, School of Medicine, Zhejiang University","startDate":"2026-05-01","conditions":"Osteomyelitis (Refractory)","enrollment":280},{"nctId":"NCT05764733","phase":"PHASE4","title":"Bone, Exercise, Alendronate, and Caloric Restriction","status":"RECRUITING","sponsor":"Wake Forest University Health Sciences","startDate":"2023-06-08","conditions":"Bone Loss","enrollment":900},{"nctId":"NCT01631214","phase":"PHASE3","title":"Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis","status":"COMPLETED","sponsor":"Amgen","startDate":"2012-05-04","conditions":"Postmenopausal Women With Osteoporosis","enrollment":4093},{"nctId":"NCT05602493","phase":"PHASE3","title":"A Randomized Control Trial Phase (IIIa) Unicentric, Placebo Controlled, Double-Blinded Efficacy and Safety of Topical Alendronic Acid on Alveolar Bone Remodeling After Tooth Extraction","status":"ACTIVE_NOT_RECRUITING","sponsor":"Xeolas Pharmaceuticals Limited","startDate":"2022-11-22","conditions":"Bone Loss, Alveolar","enrollment":60},{"nctId":"NCT00480766","phase":"PHASE3","title":"A Research Study to Evaluate the Safety and Effectiveness of MK0217 to Prevent and Treat Bone Loss (0217-193)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2001-07","conditions":"Osteoporosis","enrollment":173},{"nctId":"NCT00092014","phase":"PHASE3","title":"A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2002-09-01","conditions":"Postmenopausal Osteoporosis","enrollment":1053},{"nctId":"NCT00092027","phase":"PHASE3","title":"A Study to Evaluate the Safety and Tolerability of MK0217 in Women (0217-219)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2003-03-19","conditions":"Postmenopausal Osteoporosis","enrollment":454},{"nctId":"NCT02944799","phase":"PHASE2","title":"Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis","status":"COMPLETED","sponsor":"University of Aarhus","startDate":"2015-12","conditions":"Rheumatoid Arthritis, Osteoporosis","enrollment":69},{"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":"NCT05397938","phase":"PHASE2","title":"Efficacy and Safety of JMT103 in the Treatment of Glucocorticoid Induced Osteoporosis","status":"UNKNOWN","sponsor":"Shanghai JMT-Bio Inc.","startDate":"2022-06-15","conditions":"Glucocorticoid Induced Osteoporosis","enrollment":231},{"nctId":"NCT02322099","phase":"PHASE4","title":"Alendronate for Prevention of AntiRetroviral Therapy-associated Bone Loss","status":"TERMINATED","sponsor":"University College Dublin","startDate":"2016-05","conditions":"Bone Demineralization","enrollment":53},{"nctId":"NCT05305183","phase":"PHASE3","title":"A Phase III Clinical Study of Minodronate Tablets in Postmenopausal Women With Osteoporosis","status":"UNKNOWN","sponsor":"Shandong New Time Pharmaceutical Co., LTD","startDate":"2022-05-31","conditions":"Osteoporosis","enrollment":330},{"nctId":"NCT00398931","phase":"PHASE3","title":"FLEX - Long-term Extension of FIT (Fracture Intervention Trial)(0217-051)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"1998-02","conditions":"Osteoporosis, Postmenopausal","enrollment":1099},{"nctId":"NCT00641771","phase":"PHASE1","title":"4-Week Study to Assess the Effect of Alendronate and Vitamin D3 Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women (0217A-230)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2004-05","conditions":"Osteoporosis","enrollment":56},{"nctId":"NCT00921557","phase":"PHASE2","title":"Safety and Effectiveness of Alendronate for Bone Mineral Density in HIV-infected Children and Adolescents","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2009-11","conditions":"HIV Infection","enrollment":52},{"nctId":"NCT02132026","phase":"PHASE2","title":"Study Investigating the Effect of Drugs Used to Treat Osteoporosis on the Progression of Calcific Aortic Stenosis.","status":"COMPLETED","sponsor":"University of Edinburgh","startDate":"2014-11-12","conditions":"Calcific Aortic Stenosis","enrollment":152},{"nctId":"NCT03197623","phase":"PHASE1","title":"Safety and Tolerability of Intravenous LLP2A-Alendronate for Osteopenia Secondary to Glucocorticoids","status":"COMPLETED","sponsor":"Nancy E. Lane, MD","startDate":"2016-10-14","conditions":"Osteopenia, Osteoporosis, Osteonecrosis","enrollment":58},{"nctId":"NCT01657162","phase":"PHASE3","title":"Twenty-Four Month Extension Study of BA058-05-003 (Abaloparatide) in Participants With Osteoporosis","status":"COMPLETED","sponsor":"Radius Health, Inc.","startDate":"2012-11-20","conditions":"Postmenopausal Osteoporosis","enrollment":1139},{"nctId":"NCT01101048","phase":"PHASE1","title":"An Ascending Multiple Dose Study Evaluating AMG 167 in Healthy Men and Postmenopausal Women With Low Bone Mineral Density","status":"COMPLETED","sponsor":"Amgen","startDate":"2010-06","conditions":"Osteopenia","enrollment":74},{"nctId":"NCT00885170","phase":"PHASE2","title":"A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (MK-0822-042)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2009-04-13","conditions":"Osteoporosis","enrollment":246},{"nctId":"NCT00920075","phase":"","title":"Alendronate in Juvenile Osteoporosis","status":"COMPLETED","sponsor":"Medical University of South Carolina","startDate":"2009-07","conditions":"Juvenile Osteoporosis, Low Bone Density, Fractures","enrollment":11},{"nctId":"NCT02230332","phase":"PHASE2, PHASE3","title":"Alendronate to Prevent Loss of Bronchoprotection in Asthma","status":"COMPLETED","sponsor":"Milton S. Hershey Medical Center","startDate":"2015-01","conditions":"Asthma","enrollment":78},{"nctId":"NCT02645799","phase":"PHASE2","title":"BLADE-PCI Trial (BLADE); PHASE IIB LIPOSOMAL ALENDRONATE STUDY","status":"UNKNOWN","sponsor":"BIOrest Ltd.","startDate":"2016-04","conditions":"Diabetes Mellitus","enrollment":270},{"nctId":"NCT00001728","phase":"PHASE2","title":"Alendronate to Treat Polyostotic Fibrous Dysplasia and McCune-Albright Syndrome","status":"COMPLETED","sponsor":"National Institute of Dental and Craniofacial Research (NIDCR)","startDate":"1998-08-24","conditions":"Polyostotic Fibrous Dysplasia","enrollment":40},{"nctId":"NCT02057263","phase":"PHASE1","title":"The Effect of Alendronate on the Immune Response to Hepatitis B Vaccine in Healthy Adults","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2014-04","conditions":"Hepatitis B","enrollment":28},{"nctId":"NCT01131884","phase":"NA","title":"Pilot Study of Fosamax in Spinal Cord Injury","status":"TERMINATED","sponsor":"University of Rochester","startDate":"2010-06","conditions":"Spinal Cord Injury, Osteoporosis","enrollment":1},{"nctId":"NCT00996801","phase":"PHASE2","title":"MK-5442 in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate (MK-5442-012)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2009-11","conditions":"Osteoporosis, Postmenopausal Osteoporosis","enrollment":526},{"nctId":"NCT01552122","phase":"PHASE3","title":"Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Alendronate (MK-0822-050)","status":"WITHDRAWN","sponsor":"Merck Sharp & Dohme LLC","startDate":"2012-05","conditions":"Osteoporosis, Postmenopausal Osteoporosis","enrollment":""},{"nctId":"NCT02461667","phase":"PHASE2, PHASE3","title":"Alendronate Compared to Metformin in Chronic Periodontitis","status":"COMPLETED","sponsor":"Government Dental College and Research Institute, Bangalore","startDate":"2014-07","conditions":"Chronic Periodontitis","enrollment":108},{"nctId":"NCT00460057","phase":"PHASE4","title":"The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women With Bone Loss","status":"COMPLETED","sponsor":"Eulji University Hospital","startDate":"2006-03","conditions":"Osteoporosis","enrollment":63},{"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":"NCT01812551","phase":"PHASE3","title":"Treatment of Low Bone Density in Cystic Fibrosis.","status":"COMPLETED","sponsor":"Istituto Auxologico Italiano","startDate":"2002-10","conditions":"Osteoporosis, Cystic Fibrosis","enrollment":171},{"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},{"nctId":"NCT00504166","phase":"PHASE4","title":"Alendronate Prevents Microarchitectural Deterioration of Trabecular Bone in Early Postmenopausal Women","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2006-02","conditions":"Osteopenia, Osteoporosis","enrollment":53},{"nctId":"NCT00463268","phase":"PHASE3","title":"Osteoporosis Prevention With Low Dose Alendronate","status":"COMPLETED","sponsor":"University Hospital of Mont-Godinne","startDate":"2007-09","conditions":"Osteopenia","enrollment":83},{"nctId":"NCT00891553","phase":"","title":"CR9112792, a Follow-up of Study CR9108963","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-03","conditions":"Osteoporosis","enrollment":171},{"nctId":"NCT00532337","phase":"PHASE2","title":"Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis","status":"COMPLETED","sponsor":"Ono Pharma USA Inc","startDate":"2007-10","conditions":"Osteoporosis, Osteopenia","enrollment":285},{"nctId":"NCT00330460","phase":"PHASE3","title":"A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density.","status":"COMPLETED","sponsor":"Amgen","startDate":"2006-05","conditions":"Osteoporosis, Osteopenia","enrollment":1189},{"nctId":"NCT00259857","phase":"PHASE2","title":"Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis","status":"COMPLETED","sponsor":"Medical University of South Carolina","startDate":"2003-10","conditions":"Osteoporosis","enrollment":22},{"nctId":"NCT00157690","phase":"PHASE4","title":"Study of Alendronate to Prevent and Treat Osteoporosis in Cystic Fibrosis Patients","status":"COMPLETED","sponsor":"McMaster University","startDate":"2003-12","conditions":"Cystic Fibrosis, Osteoporosis, Bone Diseases, Metabolic","enrollment":56}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"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":"Placebo to Alendronate","genericName":"Placebo to Alendronate","companyName":"Amgen","companyId":"amgen","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Alendronate works by inhibiting osteoclast-mediated bone resorption. Used for Treatment of osteoporosis in postmenopausal women and men, Treatment of glucocorticoid-induced osteoporosis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}