Treatment-related changes in total hip bone mineral density are applicable to trials of varied study designs and to drugs with differing mechanisms of action: meta-regression results from the FNIH-ASBMR SABRE study
Authors' conclusion
Our analyses indicate robust associations between treatment-induced THBMD changes and fracture risk reduction across various anti-osteoporosis therapies and trial designs, suggesting that treatment-induced changes in THBMD predict anti-fracture efficacy regardless of drug mechanism or trial design.
Study context
- Population
- Individual patient data from 22 randomised, placebo-controlled trials (17 antiresorptive, 3 PTH analogs, 1 odanacatib, 1 romosozumab) and 3 trials of an anabolic followed by an antiresorptive22 placebo-controlled + 3 sequential-therapy RCTs
- Comparison
- Association of treatment-related total hip BMD changes with fracture risk reduction, by drug mechanism and trial design
- Anabolic followed by antiresorptiven = 3 trials
- Outcome
- Study-level association (r2) between treatment-related total hip BMD changes and fracture risk reduction (radiologic vertebral and all clinical fractures)
- Follow-up
- 12 and 24 mo
Methodological detailsstudy-level meta-regression, FNIH-ASBMR SABRE study
- Study-level meta-regression
- FNIH-ASBMR SABRE study
Pooled result
As reported in the abstract
Vertebral fractures: r2 for THBMD change vs fracture risk reduction, placebo-controlled trials
| Group | Value | r2 at 24 mo | r2 at 12 mo |
|---|---|---|---|
| All drugs | r2 0.73 | 0.73 (p = .0001) | 0.59 (p = .0003) |
| Antiresorptive drugs | r2 0.78 | 0.78 (p = .0002) | 0.70 (p = .0007) |
Value
All drugsr2 0.73
Antiresorptive drugsr2 0.78
r2 at 24 mo
All drugs0.73 (p = .0001)
Antiresorptive drugs0.78 (p = .0002)
r2 at 12 mo
All drugs0.59 (p = .0003)
Antiresorptive drugs0.70 (p = .0007)
Further pooled results
| Outcome | All drugs | Antiresorptive drugs |
|---|---|---|
| All clinical fractures: r2 for THBMD change vs fracture risk reduction, placebo-controlled trials | r2 0.71 | r2 0.65 |
| r2 at 24 mo | 0.71 (p < .0001) | 0.65 (p = .0009) |
| r2 at 12 mo | 0.46 (p = .0007) | 0.51 (p = .002) |
- All clinical fractures: r2 for total hip BMD (THBMD) change vs fracture risk reduction, placebo-controlled trials: value = r2 at 24 mo
Trials of an anabolic followed by an antiresorptive
- Association between THBMD change and fracture risk reduction similar to that for placebo-controlled monotherapy trials
Original publication
Treatment-related changes in total hip bone mineral density are applicable to trials of varied study designs and to drugs with differing mechanisms of action: meta-regression results from the FNIH-ASBMR SABRE study. J Bone Miner Res. Published 26 July 2025. doi:10.
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