Romosozumab in patients who experienced an on-study fracture: post hoc analyses of the FRAME and ARCH phase 3 trials
Authors' conclusion
Data suggest support for the efficacy and safety of continuing romosozumab treatment following fracture.
Study context
- Population
- Postmenopausal women with osteoporosis who experienced on-study nonvertebral or new/worsening vertebral fracture by Month 12
- Comparison
- Romosozumab 210 mg monthly vs comparator (FRAME, placebo; ARCH, alendronate 70 mg weekly) for 12 months, then antiresorptive therapy, in patients with on-study fracture
- Primary endpoint
- Fracture incidence after on-study fracture
- Follow-up
- Through 36 months
Methodological detailsrandomized 1:1
- Randomized 1:1
Primary result
As reported in the abstract
| Group | Value | Denominator |
|---|---|---|
| Romosozumab (FRAME) | 3.6% | 56 |
| Placebo (FRAME) | 9.2% | 76 |
| Romosozumab (ARCH) | 10.0% | 70 |
| Alendronate (ARCH) | 12.6% | 95 |
Value
Denominator
Further findings
Subsequent vertebral fracture after on-study nonvertebral fracture by Month 12 · through 36 months
Denominator Romosozumab (FRAME) 56 · Placebo (FRAME) 76 · Romosozumab (ARCH) 70 · Alendronate (ARCH) 95
Recurrent vertebral fracture after on-study vertebral fracture by Month 12 · through 36 months
Denominator Romosozumab (FRAME) 17 · Placebo (FRAME) 59 · Romosozumab (ARCH) 67 · Alendronate (ARCH) 100
Subsequent nonvertebral fracture after on-study vertebral fracture by Month 12 · through 36 months
Denominator Romosozumab (FRAME) 17 · Placebo (FRAME) 59 · Romosozumab (ARCH) 67 · Alendronate (ARCH) 100
On-study nonvertebral fracture by Month 12 (all randomised) · numerically lower
On-study vertebral fracture by Month 12 (all randomised) · numerically lower
BMD change
- BMD gains numerically greater with romosozumab than comparators
Safety
Events
| Outcome | Romosozumab (FRAME) | Romosozumab (ARCH) |
|---|---|---|
| Fracture-related complications in patients with fracture by Month 12 | 0 | 0 |
Fracture-related complications in patients with fracture by Month 12
- No fracture-related complications reported in romosozumab-treated patients
Original publication
Composed by AI from the published abstract and checked against it. How Briefs are made →