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NCT05087030 · ClinicalTrials.gov registry record · Phase 3
Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis
A Phase 3 study of Postmenopausal Osteoporosis, sponsored by Gedeon Richter.
- Completed
- Registry status
- Phase 3
- Development phase
- 473
- Enrollment target
- 20
- Study locations
NCT05087030: Completed Phase 3 study of Postmenopausal Osteoporosis, sponsored by Gedeon Richter.
NCT05087030 is a Phase 3 study of Postmenopausal Osteoporosis that has completed, run by Gedeon Richter. The registered enrollment target is 473 participants, roughly in line with the 487-participant average among 14 other Postmenopausal Osteoporosis trials with a reported enrollment target. The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05087030, a Phase 3 study of Postmenopausal Osteoporosis, has completed, sponsored by Gedeon Richter.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 473 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Percentage change from baseline in lumbar bone BMD was assessed. BMD at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA). This outcome measure was assessed for main period.
Conditions Studied
Interventions
- DRUG RGB-14-P
- DRUG Prolia®
Study Locations (20)
Other
- Medical Center Medconsult Pleven - Pleven
- UMHAT Kaspela - Plovdiv
- DKC "Sveti Georgi" - Plovdiv
- UMHAT Kaspela (Endocrinology/metabolic disease) - Plovdiv
- UMHAT Pulmed - Reumathology - Plovdiv
- UMHAT Plovdiv - Plovdiv
- Medical Center - Teodora EOOD - Rousse
- Medical Center Excelsior - Sofia
- "DCC XVII-Sofia" EOOD - Sofia
- FN Hradec Kralove - Hradec Králové
- Klatovska nemocnice, a.s. - Klatovy
- Fakultni nemocnice Plzen - Pilsen
- Revmatologicky ustav - Prague
- Affidea Praha s.r.o. - Prague
Florida
- Miami Clinical Research - Miami
- Global Health Research Center - Miami Lakes
Georgia
- iResearch Atlanta, LLC - Decatur
Nevada
- Excel Clinical Research - Internal Medicine - Las Vegas
Sofia-Grad
- Medical Center Hera EOOD - Rheumatology Office - Sofia
Ostrava-město
- APAVAR Lekarna - Ostrava
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 473 participants |
| Start Date | 2021-09-21 |
| Est. Completion | 2023-11-15 |
| Phase | Phase 3 |
What the finished NCT05087030 record still lists
NCT05087030 is an interventional study that assigns participants to a tested intervention. The registered 473 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 487-participant average among 14 other Postmenopausal Osteoporosis trials with a reported enrollment target.
The record links to 1 condition, with Postmenopausal Osteoporosis appearing as the primary indexed condition, and to 2 interventions - of which RGB-14-P is the first listed.
NCT05087030 names 20 study sites across 6 states, led by Other, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT05087030 about?
NCT05087030 is a clinical study titled "Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis". 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.
What is the current status of trial NCT05087030?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 473 participants. The study started on 2021-09-21. Estimated completion is 2023-11-15.
What conditions does trial NCT05087030 study?
This clinical trial studies the following conditions: Postmenopausal Osteoporosis.
What interventions are being tested in trial NCT05087030?
The interventions under investigation include: RGB-14-P (DRUG), Prolia® (DRUG).
Who is sponsoring clinical trial NCT05087030?
This trial is sponsored by Gedeon Richter, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05087030 being conducted?
This trial has 20 study locations across Florida, Georgia, Nevada, Sofia-Grad, Ostrava-město. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Postmenopausal Osteoporosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05087030's enrollment target sits among peer trials
473 6th of 14 higher than 9 of 14 other Postmenopausal Osteoporosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postmenopausal Osteoporosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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