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Monoclonal Antibodies

RGB-14-P + Prolia® for Osteoporosis

Phase 3
Waitlist Available
Research Sponsored by Gedeon Richter Plc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78
Awards & highlights

Summary

This trial is testing a new drug, RGB-14-P, against an existing drug, Prolia®, in postmenopausal women with osteoporosis. The goal is to see if RGB-14-P is as effective as Prolia® in strengthening bones by slowing down bone breakdown. Prolia® is already approved for treating postmenopausal osteoporosis in women at high risk of fractures.

Eligible Conditions
  • Postmenopausal Osteoporosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area under the effective curve after the first dose until Day 183 of percent change from baseline in serum type I collagen C-telopeptide up to month 6 (AUEC of %CfB in sCTX00-m6) until Week 26
Percentage change from baseline in lumbar spine bone mineral density (BMD)
Secondary study objectives
Non-vertebral fragility fracture incidence
Number of participants with adverse events (AEs)
Number of participants with anti-drug antibodies (ADAs) and neutralizing antibodies
+7 more

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: RGB-14-P (Transition period)Experimental Treatment1 Intervention
Re-randomized participants will receive SC injection of RGB-14-P, on Day 1 of Treatment period 3.
Group II: RGB-14-P (Main period)Experimental Treatment1 Intervention
Randomized participants will receive subcutaneous (SC) injection of RGB-14-P, on Day 1 of Treatment periods 1 and 2.
Group III: RGB-14-P (Continued till transition period)Experimental Treatment1 Intervention
Randomized participants will continue to receive SC injection of RGB-14-P from the main period till Day 1 of Treatment period 3.
Group IV: Prolia® (Main period)Active Control1 Intervention
Randomized participants will receive SC injection of Prolia®, on Day 1 of Treatment periods 1 and 2.
Group V: Prolia® (Transition period)Active Control1 Intervention
Re-randomized participants will receive SC injection of Prolia®, on Day 1 of Treatment period 3.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RGB-14-P
2021
Completed Phase 3
~480

Find a Location

Who is running the clinical trial?

Gedeon Richter Plc.Lead Sponsor
11 Previous Clinical Trials
3,203 Total Patients Enrolled

Media Library

Prolia® (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05087030 — Phase 3
Osteoporosis Research Study Groups: RGB-14-P (Main period), Prolia® (Main period), RGB-14-P (Transition period), Prolia® (Transition period), RGB-14-P (Continued till transition period)
Osteoporosis Clinical Trial 2023: Prolia® Highlights & Side Effects. Trial Name: NCT05087030 — Phase 3
Prolia® (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05087030 — Phase 3
~121 spots leftby Sep 2025
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