A randomised Phase 3 study comparing the efficacy and safety of proposed denosumab biosimilar RGB-14-P and reference denosumab in women with postmenopausal osteoporosis
Primary result · Lumbar spine BMD, adjusted mean %CfBResult — go to the resultEstimated difference 0.34 95% CI - 0.40, 1.09Authors' conclusion
In women with postmenopausal osteoporosis, RGB-14-P demonstrated equivalent efficacy and pharmacodynamics, and similar immunogenicity and safety to denosumab.
Study context
- Population
- Women with postmenopausal osteoporosisrandomised and received study drug
- Participants
- 473 women
- Comparison
- Proposed denosumab biosimilar RGB-14-P vs reference denosumab, 60 mg SC every 6 months
- RGB-14-Pn = 242
- Denosumabn = 231reference
- Primary endpoint
- Co-primary: %CfB in lumbar spine BMD at Week 52 and AUEC of %CfB serum CTX to Week 26
- Follow-up
- Up to Week 52
Methodological detailsmulticentre, double-blind, Phase 3, equivalence
- Multicentre
- Double-blind
- Phase 3
- Equivalence
Primary result
Lumbar spine BMD, adjusted mean %CfB
Estimated difference
0.34
95% CI - 0.40, 1.09
By group
As reported in the abstract
Secondary outcomes
Co-primary: Area under the effective curve (AUEC) of %CfB in serum CTX · to Week 26
- Geometric mean ratio in AUEC of %CfB in CTX concentration
- 1.01 (95% CI, 0.98, 1.05; P = 0.494)
- Both primary endpoints demonstrated equivalence of RGB-14-P and denosumab
%CfB in total hip and femoral neck bone mineral density (BMD)
- No statistical differences
Vertebral or non-vertebral fragility fractures
- Incidence comparable between treatments
Anti-drug antibody incidence
- < 1% in both arms
Safety
| Outcome | RGB-14-P | Denosumab |
|---|---|---|
| Anti-drug antibody incidence | < 1% | < 1% |
Safety
- Comparable between groups
Original publication
A randomised Phase 3 study comparing the efficacy and safety of proposed denosumab biosimilar RGB-14-P and reference denosumab in women with postmenopausal osteoporosis. Osteoporos Int. Published 14 October 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →