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Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis

NCT05087030 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 473

Last updated 2024-10-24

Study results available
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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

  • Postmenopausal Osteoporosis

Interventions

DRUG

RGB-14-P

Participants will receive RGB-14-P into the thigh, abdomen, or upper arm as per the arm assigned.

DRUG

Prolia®

Participants will receive Prolia® into the thigh, abdomen, or upper arm as per the arm assigned.

Sponsors & Collaborators

  • Gedeon Richter Plc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-21
Primary Completion
2023-10-02
Completion
2023-11-15
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • Hungary
  • Italy
  • Poland
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05087030 on ClinicalTrials.gov