Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: a double-blind, randomized, active-controlled, Phase 3 trial in postmenopausal women with osteoporosis
Authors' conclusion
CT-P41 was equivalent to US-denosumab in women with postmenopausal osteoporosis, with respect to primary efficacy and PD endpoints.
Study context
- Population
- Postmenopausal women with osteoporosis
- Participants
- 479 women
- Comparison
- CT-P41 60 mg SC vs US reference denosumab
- Primary endpoint
- Percent change from baseline in lumbar spine BMD at Week 52
- Follow-up
- Week 52
Methodological detailsdouble-blind, active-controlled, Phase 3, equivalence, two treatment periods with re-randomisation at Week 52
- Double-blind
- Active-controlled
- Phase 3
- Equivalence
- Two treatment periods with re-randomisation at Week 52
Primary result
As reported in the abstract
% change from baseline in lumbar spine BMD
Least squares (LS) mean difference
- 0.139
95% CI - 0.826, 0.548
full analysis set
LS mean difference
- 0.280
95% CI - 0.973, 0.414
per-protocol set
Secondary outcomes
| Outcome | Geometric LS mean ratio (95% CI) |
|---|---|
| Primary PD endpoint: AUC of serum CTX through first 26 weeksEquivalence margin 80-125%; equivalence demonstrated | 94.94 (90.75–99.32) |
Secondary efficacy, pharmacodynamic (PD) and pharmacokinetics up to Week 78
- Comparable among all groups, including after transitioning to CT-P41 from US-denosumab
Safety
- Comparable among all groups up to Week 78, including after transitioning to CT-P41 from US-denosumab
Original publication
Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: a double-blind, randomized, active-controlled, Phase 3 trial in postmenopausal women with osteoporosis. Osteoporos Int. Published 23 July 2024. doi:10.
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