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Clinical Trial Summary

This study is a Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women with Osteoporosis


Clinical Trial Description

This is a double-blind, randomized, active-controlled, Phase 3 study to evaluate the efficacy, PK, PD, and safety including immunogenicity of CT-P41 compared with US-licensed Prolia in postmenopausal women with osteoporosis. All patients will also receive daily supplementation containing at least 1,000 mg of elemental calcium and at least 400 IU vitamin D from randomization to EOS visit and the data will be collected via patient's diary. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04757376
Study type Interventional
Source Celltrion
Contact
Status Completed
Phase Phase 3
Start date June 17, 2021
Completion date November 16, 2023

See also
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Active, not recruiting NCT05345691 - Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis Phase 3
Active, not recruiting NCT05338086 - A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of MB09 [Proposed Denosumab Biosimilar] to Prolia® [EU-sourced] in Postmenopausal Osteoporosis (SIMBA Study) Phase 3
Completed NCT03974100 - Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis Phase 3
Completed NCT01581320 - Phase III Clinical Trial of DP-R206 and Bonvia In Postmenopausal Women With Osteoporosis Phase 3