The relationship between treatment-related changes in total hip BMD measured after 12, 18, and 24 mo and fracture risk reduction in osteoporosis clinical trials: the FNIH-ASBMR-SABRE project
Authors' conclusion
These findings demonstrate that treatment-related THBMD changes at 12, 18, and 24 mo are associated with fracture risk reductions across trials.
Study context
- Population
- Participants in randomized, placebo-controlled, double-blind trials of osteoporosis medications (FNIH-ASBMR-SABRE project)
- Participants
- 122,235 participants22 RCTs
- Comparison
- Treatment-related total hip BMD change (active−placebo) at 12, 18 and 24 mo vs fracture risk reduction
- Outcome
- Study-level association (r2) between treatment-related differences in total hip BMD change and fracture risk reduction
- Follow-up
- BMD change at 12, 18 and 24 mo
Methodological details22 randomized, placebo-controlled, double-blind trials, study-level meta-regression, Logistic regression for radiologic vertebral fractures; Cox regression for hip, non-vertebral, all and all clinical fractures
- 22 randomized, placebo-controlled, double-blind trials
- Study-level meta-regression
- Logistic regression for radiologic vertebral fractures; Cox regression for hip, non-vertebral, all and all clinical fractures
Pooled result
As reported in the abstract
Association (r2, 95% CI) between total hip BMD change and fracture risk reduction · 12, 18 and 24 mo BMD changes
- Vertebral fractures, 12 mo
- r2 0.59 (0.19, 0.75)
- Vertebral fractures, 18 mo
- r2 0.69 (0.32, 0.82)
- Vertebral fractures, 24 mo
- r2 0.73 (0.33, 0.84)
- Hip fractures, 12 mo
- r2 0.27 (0.00, 0.54)
- Hip fractures, 18 mo
- r2 0.39 (0.02, 0.63)
- Hip fractures, 24 mo
- r2 0.41 (0.02, 0.65)
- Non-vertebral fractures, 12 mo
- r2 0.27 (0.01, 0.52)
- Non-vertebral fractures, 18 mo
- r2 0.49 (0.10, 0.69)
- Non-vertebral fractures, 24 mo
- r2 0.53 (0.11, 0.72)
- All fractures, 12 mo
- r2 0.44 (0.10, 0.64)
- All fractures, 18 mo
- r2 0.63 (0.24, 0.77)
- All fractures, 24 mo
- r2 0.66 (0.25, 0.80)
- All clinical fractures, 12 mo
- r2 0.46 (0.11, 0.65)
- All clinical fractures, 18 mo
- r2 0.64 (0.26, 0.78)
- All clinical fractures, 24 mo
- r2 0.71 (0.32, 0.83)
Original publication
The relationship between treatment-related changes in total hip BMD measured after 12, 18, and 24 mo and fracture risk reduction in osteoporosis clinical trials: the FNIH-ASBMR-SABRE project. J Bone Miner Res. Published 4 August 2024. doi:10.
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