Fragility of Evidence for the Efficacy of Anti-Fracture Medications
Authors' conclusion
The existing RCT evidence of anti-fracture efficacy is highly fragile. The FI, its comparison with loss to follow-up and FQ should be incorporated into clinical guideline development and doctor-patient risk communication.
Study context
- Population
- Phase 3/4 randomized controlled trial (RCTs) in high-impact medical journals assessing anti-fracture efficacy, 1:1 allocation to pharmacological intervention or control, with a statistically significant result
- Participants
- 27 RCTs
- Outcome
- Fragility Index
Methodological detailsretrospective analysis of RCTs, phase 3/4 RCTs, 1:1 allocation, high-impact medical journals
- Retrospective analysis of RCTs
- Phase 3/4 RCTs
- 1:1 allocation
- High-impact medical journals
Main finding
As reported in the abstract
Median Fragility Index (FI) (IQR: 4, 19)
9
Observational data: associations, not effects.
Further findings
Loss to follow-up exceeding FI
- Analyses in which number lost to follow-up exceeded the FI
- 60%
FI by medication
- Romosozumab, FI (IQR: 7.0, 31.5); most robust
- 19.5
- Denosumab, FI (IQR 3, 17); least robust
- 4
- Calcium/vitamin D supplementation, FI (IQR 2.3, 16.8); least robust
- 7.0
FI by result characteristics
- Fractures as primary endpoint, FI (IQR 11, 33)
- 14
- P value < .001, FI (IQR 18, 42)
- 26
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Fragility of Evidence for the Efficacy of Anti-Fracture Medications. J Clin Endocrinol Metab. Published 9 June 2025. doi:10.
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