At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 473 enrolled
Drug / intervention
RGB-14-P +1 moredrug
Likely dose
Not stated in 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 Randomised, Double Blind, Multicentre Phase III Study to Assess the Efficacy and Safety of RGB-14-P Compared to Prolia® in Women With Postmenopausal Osteoporosis
In Brief
A Phase 3 clinical trial evaluating RGB-14-P and Prolia® for Postmenopausal Osteoporosis. Completed, enrolled 473 participants across 59 sites in 8 countries.
Detailed Summary
This study will be conducted to assess the efficacy, pharmacodynamic (PD), safety, tolerability, and immunogenicity of RGB -14- P compared to US-licensed Prolia® in participants with postmenopausal osteoporosis, in a comparative manner.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostmenopausal Osteoporosis
CountriesBulgaria, Czechia, Hungary, Italy, Poland, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
Enrollment StartSep 2021
First PostedOct 2021
Primary CompletionOct 2023
Study CompletionNov 2023
TodayJul 2026
First PostedOct 21, 2021
Enrollment StartSep 21, 2021
Primary CompletionOct 2, 2023
Study CompletionNov 15, 2023
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 4.7 years ago
Interventions
RGB-14-Pdrug
Participants will receive RGB-14-P into the thigh, abdomen, or upper arm as per the arm assigned.
Prolia®drug
Participants will receive Prolia® into the thigh, abdomen, or upper arm as per the arm assigned.