NCT04757376

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 479 (actual)
• Sponsor: Celltrion · Industry
• Sex: Female
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Postmenopausal Women With Osteoporosis

Interventions

Type	Name	Description
BIOLOGICAL	CT-P41	60 mg/mL single dose, Solution for injection in PFS
BIOLOGICAL	US-licensed Prolia	60 mg/mL single dose, Solution for injection in PFS

Timeline

• Start date: 2021-06-17
• Primary completion: 2023-05-18
• Completion: 2023-11-16
• First posted: 2021-02-17
• Last updated: 2024-06-14
• Results posted: 2024-05-16

Locations

20 sites across 4 countries: Estonia, Latvia, Poland, Ukraine

Regulatory

• FDA-regulated drug study