To quantify the fragility of randomized controlled trial (RCT) evidence specifically for anti-fracture efficacy.
Key Findings:
Median FI was 9 (IQR: 4, 19), indicating that adding 9 fracture patients would eliminate statistical significance.
60% of analyses had participant loss to follow-up exceeding the corresponding FI.
Romosozumab showed the most robust evidence (FI: 19.5; IQR: 7.0, 31.5), while denosumab (FI: 4; IQR: 3, 17) and calcium/vitamin D (FI: 7; IQR: 2.3, 16.8) showed the least.
Efficacy evidence improved when fractures were the primary endpoint (FI: 14; IQR: 11, 33) or with P values < .001 (FI: 26; IQR: 18, 42).
Interpretation:
The existing RCT evidence for anti-fracture efficacy is highly fragile, which necessitates careful consideration in clinical guidelines and patient communication to avoid misinterpretation.
Limitations:
The analysis is retrospective and limited to published RCTs in high-impact journals, which may not represent all available evidence.
Potential publication bias may affect the robustness of the findings, as studies with non-significant results are less likely to be published.
Conclusion:
The fragility of anti-fracture efficacy evidence highlights the need for incorporating FI and FQ into clinical guidelines and risk communication to ensure informed decision-making.
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