Amgen: Osteoporosis trials

The registry lists 38 Osteoporosis studies with Amgen as lead sponsor. 0 are open to participants now and 35 have results posted.

Phase 1 5Phase 2 4Phase 3 21Phase 4 3No phase 5(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.CompletedNCT06079476Phase 4Results posted
• Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal WomenCompletedNCT03822078Phase 1Results posted
• A Comparison of Subject-administered Romosozumab With Healthcare Provider-administered Romosozumab for OsteoporosisCompletedNCT03432533Phase 3Results posted
• Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced OsteoporosisCompletedNCT03164928Phase 3Results posted
• A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With OsteoporosisCompletedNCT02791516Phase 3Results posted
• Persistence With Prolia® (Denosumab) in Postmenopausal Women With OsteoporosisCompletedNCT02732210Results posted
• Bone Histomorphometry in Postmenopausal Men and Women With Osteoarthritis Undergoing Total Hip ReplacementCompletedNCT02576652Phase 4Results posted
• A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With OsteoporosisCompletedNCT02186171Phase 3Results posted
• A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With OsteoporosisCompletedNCT02157948Phase 3Results posted
• A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With OsteoporosisCompletedNCT02016716Phase 3Results posted
• Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal OsteoporosisCompletedNCT01992159Phase 2Results posted
• Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring HemodialysisCompletedNCT01833754Phase 1Results posted
• An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal WomenCompletedNCT01796301Phase 3Results posted
• Observational Study of Denosumab (Prolia®) in Postmenopausal Women With OsteoporosisCompletedNCT01668589Results posted
• Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical PracticeCompletedNCT01652690Results posted
• Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With OsteoporosisCompletedNCT01631214Phase 3Results posted
• Transition From Alendronate to Romosozumab (AMG 785)CompletedNCT01588509Phase 1Results posted
• Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With OsteoporosisCompletedNCT01575834Phase 3Results posted
• Effects of Denosumab on the Pharmacokinetics of EtanerceptTerminatedNCT01294397Phase 1Results posted
• The Effects of Denosumab on the Pharmacokinetics (PK) of MidazolamCompletedNCT01221727Phase 1Results posted
• Study to Compare the Efficacy and Safety of DenosumAb Versus Placebo in Males With OsteoporosisCompletedNCT00980174Phase 3Results posted
• A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly BisphosphonatesCompletedNCT00936897Phase 3Results posted
• Evaluation of New or Worsening Lens Opacifications in Men With Non-metastatic Prostate Cancer Receiving Denosumab for Bone LossCompletedNCT00925600Phase 3Results posted
• Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate TherapyCompletedNCT00919711Phase 3Results posted
• A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With DenosumabCompletedNCT00890981Phase 3Results posted
• A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With DenosumabCompletedNCT00887965Phase 2Results posted
• Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of OsteoporosisCompletedNCT00523341Phase 3Results posted
• Denosumab Adherence Preference Satisfaction StudyCompletedNCT00518531Phase 3Results posted
• A Multi-Center, Randomized, Open-Label Study to Assess the Immunogenicity and Safety of Denosumab in Pre-filled Syringe Compared to Vial in Subjects With Low Bone Mineral DensityCompletedNCT00515463Phase 3Results posted
• Study of Transitioning From Alendronate to DenosumabCompletedNCT00377819Phase 3Results posted
• A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density.CompletedNCT00330460Phase 3Results posted
• A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic SubjectsCompletedNCT00306189Phase 2Results posted
• 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 DensityCompletedNCT00293813Phase 2Results posted
• Study to Evaluate AMG 162 in the Prevention of Postmenopausal OsteoporosisCompletedNCT00091793Phase 3Results posted
• A Study to Evaluate Denosumab in the Treatment of Postmenopausal OsteoporosisCompletedNCT00089791Phase 3Results posted
• Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland ChinaActive, not recruitingNCT06332014Phase 4
• Denosumab Safety Assessment in Multiple Observational DatabasesCompletedNCT02520362
• Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in FranceCompletedNCT02347865