ROMosozumab early experience in female patients with severe osteoporosis in an Italian real-world setting, the ROMEO study
Authors' conclusion
The rapid increase in BMD with romosozumab supports its use for reducing fracture risk in postmenopausal women with severe osteoporosis, regardless of prior bisphosphonate exposure.
Study context
- Population
- Postmenopausal women with severe osteoporosis newly treated with romosozumab, Italian real-world setting, 29 November 2022 to 01 July 202470 followed to month 6, 41 to month 12
- Participants
- 133 women
- Outcome
- Achievement of BMD surrogate threshold effect (bone mineral density surrogate threshold effect (BMD-STE)) for minimal fracture risk reduction
Methodological detailsreal-world, single-arm
- Real-world
- Single-arm
Main finding
As reported in the abstract
Patients reaching the BMD-STE for minimal fracture risk reduction for all fractures · up to month 6
Reached the STE for minimal fracture risk reduction for all fractures
56.4%
Observational data: associations, not effects.
Further findings
BMD (lumbar spine, femoral neck, total hip)
- Significant increases in BMD at all sites (all p < 0.05 vs. baseline)
T-score target (> −2.5) reached among patients with baseline lumbar spine T-score ≤ −2.5 · months 6 and 12
- Month 6
- 18.2%
- Month 12
- 32.0%
Bone turnover markers · months 3 and 6
- P1nP increased significantly and CTX decreased significantly (all p < 0.05 vs. baseline)
Original publication
ROMosozumab early experience in female patients with severe osteoporosis in an Italian real-world setting, the ROMEO study. Osteoporos Int. Published 13 October 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →