RGB-14-P + Prolia® for Osteoporosis

Recruiting at 61 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

473 Participants Needed

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. ^{1 2 3 4 5}

What safety data exists for RGB-14-P and Prolia® in humans?

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 (a rare condition where the jawbone starts to die). ^{6 7 8 9 10}

How is the drug RGB-14-P + Prolia® unique for treating osteoporosis?

The combination of RGB-14-P with Prolia® for osteoporosis is unique because it potentially offers a novel mechanism of action or enhanced efficacy compared to existing treatments, although specific details about RGB-14-P are not provided in the available research. ^{11 12 13 14 15}

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

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

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

Treatment Details

Interventions

• Prolia®
• RGB-14-P

Participant Groups

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)

Findings from Research

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Identification, diagnostics and guideline conform therapy of osteoporosis (DVO) in trauma patients : a treatment algorithm]. [2018]

2. England pubmed.ncbi.nlm.nih.gov

The Global Longitudinal Study of Osteoporosis in Women (GLOW): rationale and study design. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Fracture mortality: associations with epidemiology and osteoporosis treatment. [2022]

4. England pubmed.ncbi.nlm.nih.gov

UK clinical guideline for the prevention and treatment of osteoporosis. [2023]

5. England pubmed.ncbi.nlm.nih.gov

A comparison of case-finding strategies in the UK for the management of hip fractures. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Safety assessment of raloxifene over eight years in a clinical trial setting. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Adverse drug reactions to osteoporosis treatments. [2019]

8. England pubmed.ncbi.nlm.nih.gov

A real-world pharmacovigilance study of abaloparatide based on the FDA Adverse Event Reporting System (FAERS). [2023]

9. England pubmed.ncbi.nlm.nih.gov

The position of strontium ranelate in today's management of osteoporosis. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Osteoporosis treatments and adverse events. [2009]

11. Germany pubmed.ncbi.nlm.nih.gov

Surgical treatment of osteoporotic thoraco-lumbar compressive fractures: the use of pedicle screw with augmentation PMMA. [2022]

12. Sweden pubmed.ncbi.nlm.nih.gov

In vitro comparison of Refobacin-Palacos R with Refobacin Bone Cement and Palacos R + G. [2014]

13. Germany pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the polymethylmethacrylate-augmented thoracic and lumbar pedicle screw fixation guided by the three-dimensional navigation for the osteoporosis patients. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Minimally invasive spinal arthrodesis in osteoporotic population using a cannulated and fenestrated augmented screw: technical description and clinical experience. [2021]

15. China pubmed.ncbi.nlm.nih.gov

[A biomechanical study on the bone repairing ability of recombinant human bone morphogenetic protein-2-coral composited artificial bone]. [2013]