Romosozumab Efficacy in Postmenopausal Women With No Prior Fracture Who Fulfill Criteria for Very High Fracture Risk
Authors' conclusion
Romosozumab significantly reduced vertebral, clinical, and nonvertebral fracture risk and increased the BMD more than placebo in women at VHFR.
Study context
- Population
- Postmenopausal women in FRAME with no fracture history at baseline who met AACE very high fracture risk criteria (lumbar spine or total hip T-score <−3.0 and/or FRAX major osteoporotic fracture >30% or hip fracture >4.5%)of 7180 in FRAME
- Participants
- 2,825 women
- Comparison
- Romosozumab vs placebo for 12 months, each followed by denosumab for 12 months
- Primary endpoint
- Incidence of new vertebral, clinical and nonvertebral fractures; mean BMD % change from baseline
- Follow-up
- Years 1 and 2
Primary result
As reported in the abstract
Fracture incidence · year 1
RRR, new vertebral fracture
76%
P < 0.05
Romosozumab
RRR, clinical fracture
60%
P < 0.05
Romosozumab
RRR, nonvertebral fracture
54%
P < 0.05
Romosozumab
Further findings
| Outcome | Estimate | P value |
|---|---|---|
| Fracture incidence, romosozumab-to-denosumab vs placebo-to-denosumab · year 2Romosozumab vs Placebo | RRR, new vertebral fracture 77% | P < 0.05 |
| Fracture incidence, romosozumab-to-denosumab vs placebo-to-denosumab · year 2Romosozumab vs Placebo | RRR, clinical fracture 54% | P < 0.05 |
| Fracture incidence, romosozumab-to-denosumab vs placebo-to-denosumab · year 2Romosozumab vs Placebo | RRR, nonvertebral fracture 46% | P < 0.05 |
Mean bone mineral density (BMD) % change from baseline · years 1 and 2
- Mean BMD changes in both groups similar to those in the overall FRAME population
Original publication
Romosozumab Efficacy in Postmenopausal Women With No Prior Fracture Who Fulfill Criteria for Very High Fracture Risk. Endocr Pract. Published 4 July 2023. doi:10.
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