Setrusumab for the treatment of osteogenesis imperfecta: 12-month results from the phase 2b asteroid study
An erratum to this article was published (J Bone Miner Res, 21 Apr 2025 ↗)
Authors' conclusion
Asteroid demonstrated a beneficial effect of setrusumab on estimates of bone strength across the different types of OI
Study context
- Population
- Adults with clinical osteogenesis imperfecta (OI) type I, III or IV, a pathogenic COL1A1/A2 variant and a recent fragility fracturerandomized 1:1:1:1
- Participants
- 110 adults
- Comparison
- Setrusumab 2, 8 or 20 mg/kg vs placebo
- Primary endpoint
- Change in distal radial trabecular vBMD from baseline
- Follow-up
- Month 12
Methodological detailsphase 2b, double-blind, placebo-controlled, dose-ranging
- Phase 2b
- Double-blind
- Placebo-controlled
- Dose-ranging
Primary result
As reported in the abstract
Distal radial trabecular vBMD change from baseline · 12 mo
- No changes in radial trabecular volumetric bone mineral density (vBMD)
- p>05
Further findings
Mean
| Outcome | 8 mg/kg | 20 mg/kg |
|---|---|---|
| Failure load (microFE-derived), change from baseline · 12 moSignificant increase | — not stated in the abstract | 3.17% (SE 1.26%) |
| Stiffness (microFE-derived), change from baseline · 12 moSignificant increase | 3.06% (SE 1.70%) | 3.19% (SE 1.29%) |
— not stated in the abstract
Failure load and stiffness by OI type
- Gains in failure load and stiffness similar across OI types
Annualized fracture rates
- No significant differences between doses
Safety
- Related serious adverse reactions — 20 mg/kg
- 2 events
Original publication
Setrusumab for the treatment of osteogenesis imperfecta: 12-month results from the phase 2b asteroid study. J Bone Miner Res. Published 16 July 2024. doi:10.
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