Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study of Postmenopausal Osteoporosis that has completed, run by Gedeon Richter. The registered enrollment target is 473 participants, below the 547-participant average among 12 other Postmenopausal Osteoporosis trials with a reported enrollment target (14% lower). The trial reports 20 study locations across 6 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05087030
The ClinicalTrials.gov registry entry for NCT05087030 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 473 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 547-participant average among 12 other Postmenopausal Osteoporosis trials with a reported enrollment target (14% lower). The listed sponsor is Gedeon Richter, which has 3 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.
-
Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteoporosis
COMPLETED · Phase 3
-
A Study of Monthly Risedronate for Osteoporosis
COMPLETED · Phase 3
-
A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis
COMPLETED · Phase 3
-
An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women
COMPLETED · Phase 3
-
Dried Plums and Bone Health in Postmenopausal Women
ACTIVE NOT RECRUITING · NA
-
A Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women wIth Low Bone MasS (ARTEMIS)
ACTIVE NOT RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.