RGB-14-P + Prolia® for Osteoporosis
Trial Summary
Will I have to stop taking my current medications?
The trial requires that participants do not use any ongoing osteoporosis treatment. If you are currently on such medication, you may need to stop taking it to participate.
What data supports the effectiveness of the drug Prolia® for osteoporosis?
The research indicates that medical treatment, including drugs like Prolia®, is associated with improved survival and prevention of new and recurrent osteoporotic fractures, which are common in osteoporosis. This suggests that Prolia® could be effective in reducing fracture risk and improving outcomes for patients with osteoporosis.12345
What safety data exists for RGB-14-P and Prolia® in humans?
How is the drug RGB-14-P + Prolia® unique for treating osteoporosis?
What is the purpose of this trial?
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.
Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive either RGB-14-P or Prolia® via subcutaneous injection
Treatment Period 2
Continuation of treatment with either RGB-14-P or Prolia®
Transition Period
Re-randomization and continuation of treatment for a subset of participants
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Prolia®
- RGB-14-P
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gedeon Richter Plc.
Lead Sponsor