Equivalence trial of proposed denosumab biosimilar GP2411 and reference denosumab in postmenopausal osteoporosis: the ROSALIA study
An erratum to this article was published (J Bone Miner Res, 5 Aug 2024 ↗)
Authors' conclusion
In conclusion, ROSALIA showed similar efficacy, PK and PD, and comparable safety and immunogenicity of GP2411 to REF-DMAb in postmenopausal osteoporosis.
Study context
- Population
- Postmenopausal women with osteoporosisrandomized 1:1
- Comparison
- Proposed biosimilar denosumab GP2411 vs reference denosumab
- Primary endpoint
- %CfB in LS-BMD
- Follow-up
- Week 52
Methodological detailsmulticenter, double-blind, integrated phase I/phase III, equivalence, re-randomized 1:1 at week 52 (switch)
- Multicenter
- Double-blind
- Integrated phase I/phase III
- Equivalence
- Re-randomized 1:1 at week 52 (switch)
Primary result
As reported in the abstract
- Similar efficacy: 95% CIs of the difference in %CfB in LS-BMD fully within prespecified equivalence margins
- Prespecified equivalence margins
Secondary outcomes
Pharmacokinetics (PK) and pharmacodynamics (PD) (primary PK/PD endpoints) · week 26
- Similarity in PK and PD was demonstrated
Immunogenicity
- Immunogenicity similar between groups and not impacted by treatment switch
New vertebral fractures
- Rate of new vertebral fractures was comparable
Safety
Treatment-emergent adverse events
- Treatment-emergent adverse events: Reference denosumab (REF-DMAb)/GP2411 76.6%
Treatment-emergent adverse events
- TEAEs comparable between groups
Original publication
Equivalence trial of proposed denosumab biosimilar GP2411 and reference denosumab in postmenopausal osteoporosis: the ROSALIA study. J Bone Miner Res. Published 29 January 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →