The relationship between baseline bone mineral density and fracture incidence in the placebo groups of randomized controlled trials using individual patient data from the FNIH-ASBMR-SABRE project
Authors' conclusion
These data support the very strong relationship between hip BMD and fracture risk and provide supporting rationale for change in TH BMD as a surrogate for fracture risk reduction in future RCTs.
Study context
- Population
- Placebo participants of 25 RCTs (FNIH-ASBMR-SABRE); mean baseline age 70.2 ± 7.2 yr, mean TH BMD T-score −1.97 ± 0.90
- Participants
- 46,666 participants25 RCTs
- Outcome
- Association of baseline TH, FN and LS BMD with fracture risk (RR per SD decrease in baseline BMD)
Methodological detailspooled individual patient data, FNIH-ASBMR-SABRE project
- Pooled individual patient data
- FNIH-ASBMR-SABRE project
Pooled result
As reported in the abstract
Fracture risk per SD decrease in baseline TH BMD
- Vertebral fracture, RR/SD
- 1.55
- Hip fracture, RR
- 2.27
- Non-vertebral fracture, RR
- 1.31
- All fractures, RR
- 1.43
- All clinical fractures, RR
- 1.35
Further pooled results
Femoral neck (FN) BMD and adjusted estimates
- Fracture risk estimates similar for FN BMD and after adjustment for age, race and study
Fracture risk per SD decrease in baseline lumbar spine (LS) BMD
- Vertebral fracture, RR/SD
- 1.56
- Non-vertebral fracture, RR (weak association)
- 1.07
- Hip fracture, RR (no association)
- 1.01
Original publication
The relationship between baseline bone mineral density and fracture incidence in the placebo groups of randomized controlled trials using individual patient data from the FNIH-ASBMR-SABRE project. J Bone Miner Res. Published 16 December 2024. doi:10.
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