Monte Carlo resampling validates use of bone mineral density change as surrogate to replace fracture in future randomized trials of osteoporosis treatments: results from FNIH-ASBMR SABRE
Authors' conclusion
Overall, the %THBMD-STE comparisons were generally consistent with the original studies' fracture risk reduction observed.
Study context
- Population
- Existing large osteoporosis treatment trials with total hip BMD at 24 mo: 11 studies with radiographic vertebral fracture, 3 with hip fracture, 5 with all clinical fractures
- Comparison
- Mean %THBMD vs lower 95% confidence limit (LCL) of %THBMD, relative to the surrogate threshold effect (STE), in indicating fracture risk reduction
- Primary endpoint
- Concordance (% of simulated trials consistent) between %THBMD-STE comparisons and observed fracture risk reduction
- Follow-up
- 24 mo
Methodological detailsMonte Carlo resampling of randomised trial data, data re-sampling from existing large trials, 1000 re-samples per study, equal numbers in treatment groups, simulated trial sizes 100, 250, 500, 750 and 1000
- Monte Carlo resampling of randomised trial data
- Data re-sampling from existing large trials
- 1000 re-samples per study
- Equal numbers in treatment groups
- Simulated trial sizes 100, 250, 500, 750 and 1000
Primary result
As reported in the abstract
Studies with ≥90% of simulated trials consistent with observed fracture risk reduction, sample size >500
Vertebral fracture, mean %THBMD: studies with ≥90% of trials consistent
9 of the 11 studies
Vertebral fracture, LCL: studies with ≥90% of trials consistent
7 of the 11 studies
Original publication
Monte Carlo resampling validates use of bone mineral density change as surrogate to replace fracture in future randomized trials of osteoporosis treatments: results from FNIH-ASBMR SABRE. J Bone Miner Res. Published 8 April 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →