A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis
Phase 3
Completed
NCT04757376
| Condition | Postmenopausal Women With Osteoporosis |
|---|
| Phase | Phase 3 |
|---|
| Sponsor | Celltrion |
|---|
| Status | Completed |
|---|
| Enrollment | 479 participants |
|---|
| Interventions | CT-P41, US-licensed Prolia |
|---|
| Start date | Jun 17, 2021 |
|---|
| Completion date | May 18, 2023 |
|---|
| Results posted | May 16, 2024 |
|---|
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
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 - Full Analysis Set (FAS)
baseline (screening), Week 52 predose · percentage change (%)
| CT-P41 | 4.9597 ± 0.29977 percentage change (%) |
|---|
| US-licensed Prolia | 5.1528 ± 0.32133 percentage change (%) |
|---|
| Mean Difference (Final Values) | -0.19 (95% CI -0.76–0.38) |
|---|
Open in BENITIONS
View on ClinicalTrials.gov
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.