drugset
drugset / Trial / NCT04757376

A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis

NCT04757376 ↗

Phase 3 Completed 479 enrolled Celltrion
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2021-06-17
Primary completion
2023-05-18
Completion
2023-11-16

Drugs

EvaluationDrugModalityDoseRoute
Subject CT-P41 Unknown 60 mg/ml —
Comparator Denosumab Monoclonal antibody 60 mg/ml —

Indications

postmenopausal osteoporosis