Phase 3
N=473
Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis
Postmenopausal Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT05087030 ↗Enrolled (actual)
473
Serious AEs
3.5%
Results posted
Oct 2024
Primary outcome: Primary: Percentage Change From Baseline (%CfB) in Lumbar Spine Bone Mineral Density (BMD) — 5.68; 5.19 Percentage change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- RGB-14-P (Drug); Prolia® (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- Female
- Sponsor
- Gedeon Richter Plc.
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline (%CfB) in Lumbar Spine Bone Mineral Density (BMD) |
5.68; 5.19 | — |
| PRIMARY Area Under the Effective Curve (AUEC) After the First Dose Until Day 183 of %CfB in Serum Type I Collagen C-telopeptide (sCTX) |
14609.67; 14134.86 | 0.494 |
| SECONDARY %CfB in Total Hip BMD |
2.42; 2.69; 2.46; 2.81; 3.35; 3.42 | 0.199 |
| SECONDARY %CfB in Lumbar Spine BMD |
3.56; 3.45; 3.98; 3.39; 3.68; 7.03 | 0.929 |
| SECONDARY %CfB in Femoral Neck BMD |
1.88; 1.94; 1.60; 2.21; 2.35; 2.42 | — |
| SECONDARY Number of Participants With Vertebral Fragility Fracture |
4; 8; 3; 4; 2 | — |
| SECONDARY Number of Participants With Non-vertebral Fragility Fracture |
4; 10; 2; 5; 3 | — |
| SECONDARY %CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP) |
22.10; 20.22; 19.85; 18.45; 17.31; 65.92 | — |
| SECONDARY %CfB in Serum Type I Collagen C-telopeptide (sCTX) |
85.87; 85.38; 84.96; 84.71; 88.08; 69.74 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
161; 158; 0; 0; 0; 158 | — |
| SECONDARY Number of Participants With Anti-drug Antibodies (ADAs) |
0; 1; 0; 0; 0; 2 | — |
| SECONDARY Number of Participants With Neutralizing Antibodies |
0; 1; 1; 1; 0; 0 | — |
| SECONDARY Titre of ADAs |
NA; 302.0; NA; NA; NA; 761.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Participant is an ambulatory postmenopausal woman, diagnosed with osteoporosis, able to walk, and not bedridden
- 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 has body weight ≥ 50 and ≤ 90 kg at the Screening Period
Participants must meet the following criteria to be enrolled in the Transition Period:
- Have been enrolled, received both doses of the test drug, and completed the scheduled Main Period (up to Week 52) of the RGB-14-101 study
Exclusion Criteria
- Participant has a history and/or presence of a severe or more than two moderate vertebral fractures as determined by central reading of lateral spine X-ray during the Screening Period
- Participant has a history and/or presence of hip fracture
- Participant has a history and/or presence of atypical femur fracture
- Participant presents with an active healing fracture
- Participant has a bilateral hip replacement (unilateral is allowed if the other hip is evaluable with DXA)
- Participant has a vitamin D deficiency
- Participant has hypocalcaemia or hypercalcemia at the Screening Period
- Participant has a history and/or presence of bone metastases, renal osteodystrophy, osteomyelitis, any metabolic, endocrine or traumatic bone disease
- Participant has a current uncontrolled status of hypothyroidism or hyperthyroidism
- Participant has a history (within 5 years prior to Screening) and/or current hypoparathyroidism or hyperparathyroidism
- Participant has malignancy within 5 years before Screening
- Participant has a history and/or presence of significant cardiac disease
- Participant has a known intolerance or malabsorption of calcium or vitamin D supplements
- Participant shows contraindications to denosumab therapy (e.g., hypocalcaemia), or calcium or vitamin D supplementation before starting test drug administration
- Participant has a latex allergy
- Participant has a history and/or presence of osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures
- Participant has history and/or presence of osteonecrosis of the external auditory canal
- Participant requiring ongoing use of any osteoporosis treatment
- Participant has previously received denosumab or biosimilar denosumab
- Participant has weight or girth measurements which may preclude accurate DXA measurements
- Participant has an active infection, including, but not limited to severe acute respiratory syndrome coronavirus-2, hepatis B, hepatitis C and human immunodeficiency virus infections during the Screening Period
Data sourced from ClinicalTrials.gov (NCT05087030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.