At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 479 enrolled
Drug / intervention
CT-P41 +1 morebiological
Likely dose
CT-P41 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating CT-P41 and US-licensed Prolia for Postmenopausal Women With Osteoporosis. Completed, enrolled 479 participants across 20 sites in 4 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Women With Osteoporosis
CountriesEstonia, Latvia, Poland, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedFeb 2021
Enrollment StartJun 2021
Primary CompletionMay 2023
Study CompletionNov 2023
TodayJul 2026
First PostedFeb 17, 2021
Enrollment StartJun 17, 2021
Primary CompletionMay 18, 2023
Study CompletionNov 16, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.4 years ago
Interventions
CT-P41biological
60 mg/mL single dose, Solution for injection in PFS
US-licensed Proliabiological
60 mg/mL single dose, Solution for injection in PFS