RGB-14-P + Prolia® for Osteoporosis

No longer recruiting at 77 trial locations

Overseen By Balázs Siminszky

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Gedeon Richter Plc.

Must not be taking: Osteoporosis treatments, Denosumab

Disqualifiers: Severe fractures, Hip fracture, Vitamin D deficiency, Bone metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the effectiveness of two treatments, RGB-14-P (an experimental treatment) and Prolia®, for postmenopausal women with osteoporosis—a condition that weakens bones, making them fragile and more likely to break. The study will evaluate the effectiveness, safety, and tolerability of these treatments, as well as the body's response to them. Women diagnosed with osteoporosis who can walk without assistance might be suitable candidates for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the development of potentially groundbreaking treatments.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that RGB-14-P, a treatment similar to Prolia®, may benefit people with osteoporosis. One study found that both RGB-14-P and Prolia® improved bone health in postmenopausal women with osteoporosis, showing similar safety results. Although limited safety information exists specifically for RGB-14-P, it is being compared to Prolia®, a well-known treatment. Prolia® can sometimes cause skin reactions or, in rare cases, a serious jaw condition. The current trial phase involves testing RGB-14-P in a large group, with its safety under close observation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about RGB-14-P for osteoporosis because it offers a fresh approach to treatment. Unlike traditional options like bisphosphonates, which slow bone loss, RGB-14-P may actively promote bone formation, tackling the problem from a different angle. Additionally, the combination with Prolia®, an established treatment that reduces bone resorption, could provide a dual-action benefit, enhancing bone strength more effectively. This innovative approach could potentially lead to a more robust and comprehensive treatment for osteoporosis, offering renewed hope for patients.

What evidence suggests that this trial's treatments could be effective for osteoporosis?

Research has shown that RGB-14-P, a treatment in this trial, works as effectively as Prolia® (denosumab), another option in this trial, for treating osteoporosis in postmenopausal women. Earlier studies demonstrated that both treatments led to similar improvements in spine bone strength after one year. This indicates that RGB-14-P can strengthen bones and reduce fracture risk, comparable to Prolia®. Additionally, both treatments have proven equally safe. These findings suggest that RGB-14-P is a promising option for managing osteoporosis in postmenopausal women. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Inclusion Criteria

Participant has an absolute BMD consistent with T score ≤ 2.5 and ≥ 4.0 at the lumbar spine as measured by dual-energy X-ray absorptiometry (DXA) during the Screening Period and at least 2 lumbar vertebrae (from L1 to L4) must be evaluable by DXA

Participant is an ambulatory postmenopausal woman, diagnosed with osteoporosis, able to walk, and not bedridden

Participant has body weight ≥ 50 and ≤ 90 kg at the Screening Period

Exclusion Criteria

You have a history of serious heart problems or currently have a heart condition.

You are allergic to latex.

You have experienced or currently have a type of leg fracture called "atypical femur fracture".

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

Treatment Period 1

Participants receive either RGB-14-P or Prolia® via subcutaneous injection

26 weeks

1 visit (in-person) at Week 0

Treatment Period 2

Continuation of treatment with either RGB-14-P or Prolia®

26 weeks

1 visit (in-person) at Week 26

Transition Period

Re-randomization and continuation of treatment for a subset of participants

26 weeks

1 visit (in-person) at Week 52

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prolia®
• RGB-14-P

How Is the Trial Designed?

Group I: RGB-14-P (Transition period) Experimental Treatment 1 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 Treatment 1 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 Treatment 1 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 Control 1 Intervention

Randomized participants will receive SC injection of Prolia®, on Day 1 of Treatment periods 1 and 2.

Group V: Prolia® (Transition period) Active Control 1 Intervention

Re-randomized participants will receive SC injection of Prolia®, on Day 1 of Treatment period 3.

Who Is Running the Clinical Trial?

Gedeon Richter Plc.

Lead Sponsor

Trials

17

Recruited

173,000+

Founded

1901

Headquarters

Budapest, Hungary

Known For

Women's Health Innovations

Top Products

Reagila (cariprazine), Pegfilgrastim (biosimilar), Estelle (contraceptive)

Published Research Related to This Trial

A comprehensive analysis of 33,480 adverse events related to abaloparatide (ABL) from the FDA database revealed 99 safety signals, including 35 unexpected adverse events, indicating the need for ongoing monitoring of its safety profile.

The study highlighted that patient age may influence the severity of adverse events, with most reported issues occurring within the first week of treatment, providing valuable insights for healthcare professionals in managing potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A real-world pharmacovigilance study of abaloparatide based on the FDA Adverse Event Reporting System (FAERS). Shi, X., Cheng, Q., Zhao, YZ., et al.[2023]

Treatments for postmenopausal osteoporosis, while generally safe, can lead to rare but serious side effects such as gastrointestinal issues, musculoskeletal pain, and osteonecrosis of the jaw, particularly with bisphosphonates and denosumab.

The management of osteoporosis requires careful consideration of the potential adverse reactions against the benefits of therapy, primarily the reduction of fracture risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions to osteoporosis treatments. Rizzoli, R., Reginster, JY.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05087030

Comparative Efficacy and Safety Study of RGB-14-P ... This study will be conducted to assess the efficacy, pharmacodynamic (PD), safety, tolerability, and immunogenicity of RGB -14- P compared to US-licensed Prolia ...

2. link.springer.com link.springer.com/article/10.1007/s00198-025-07711-x

A randomised Phase 3 study comparing the efficacy and ... In this Phase 3 study in women with postmenopausal osteoporosis, RGB-14-P and denosumab demonstrated similar improvements in lumbar spine, total ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41085683/

A randomised Phase 3 study comparing the efficacy and ... In women with postmenopausal osteoporosis, RGB-14-P demonstrated equivalent efficacy and pharmacodynamics, and similar immunogenicity and ...

4. rheumatologyadvisor.com rheumatologyadvisor.com/news/fda-approves-denosumab-biosimilars-enoby-and-xtrenbo/

FDA Approves Denosumab Biosimilars Enoby and Xtrenbo Enoby is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at ...

5. springermedizin.de springermedizin.de/a-randomised-phase-3-study-comparing-the-efficacy-and-safety-of-/51574806

A randomised Phase 3 study comparing the efficacy and ... Both primary endpoints demonstrated equivalence of RGB-14-P and denosumab. Adjusted mean (95% CI) %CfB in lumbar spine BMD at Week 52 was 4.89 ( ...

6. withpower.com withpower.com/trial/phase-3-osteoporosis-8-2021-5993e

RGB-14-P + Prolia® for Osteoporosis · Info for Participants There is no specific safety data available for RGB-14-P, but Prolia® (denosumab) has been associated with skin reactions and possibly osteonecrosis of the jaw ( ...

7. ema.europa.eu ema.europa.eu/en/documents/assessment-report/junod-epar-public-assessment-report_en.pdf

Junod, INN-denosumab - European Medicines Agency Safety data collection/ Exposure. The comparative safety of RGB-14-P/ RGB-14-X and Prolia/ Xgeva has been evaluated in two clinical studies,.