Reconstruction of remodeling units reveals positive effects after 2 and 12 months of romosozumab treatment
Authors' conclusion
These data suggest that romosozumab induces a positive bone balance due to its effects on bone resorption and formation at the level of the remodeling unit, contributing to the positive effects on bone mass, structure, and fracture risk.
Study context
- Population
- Osteoporotic women at high fracture risk, FRAME trial; bone biopsies at month 12 and month 2
- Comparison
- Romosozumab vs placebo
- Primary endpoint
- Bone balance on cancellous and endocortical surfaces by remodeling site reconstruction
- Follow-up
- M12
Methodological detailsunpaired bone biopsies, remodeling site reconstruction
- Unpaired bone biopsies
- Remodeling site reconstruction
Primary result
As reported in the abstract
- Romosozumab vs Placebo: P = 0.012
- Romosozumab vs Placebo: P = 0.02
Further findings
Final erosion depth, cancellous · M12 · lower with romosozumab
P = 0.05
Completed wall thickness, endocortical · M12 · higher with romosozumab
P = 0.037
Final erosion depth, endocortical · M2 · lower with romosozumab
P = 0.021
Final erosion depth, cancellous · M2 · slightly lower with romosozumab
P = 0.11
Osteoid thickness, early endocortical formative sites (sector analysis) · M2 · higher with romosozumab
P = 0.005
Mineralized wall thickness, early endocortical formative sites (sector analysis) · M2 · higher with romosozumab
P = 0.004
Original publication
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