- Design
- Cochrane systematic review of 17 randomised trials
- Population
- 4,132 men aged 50 years or older
- Primary outcome
- Hip, vertebral and other fractures
- Effect
- Bisphosphonate vs placebo: hip RR 0.73 (0.06 to 8.51); vertebral RR 0.49 (0.14 to 1.74)
A Cochrane review pooled 17 randomised trials (4,132 men aged 50 or over) of bisphosphonates, PTH or PTHrP analogues, denosumab and romosozumab. The main comparison was bisphosphonate against placebo.
Fracture events were so few that the estimates are very imprecise: hip fracture RR 0.73 (0.06 to 8.51), symptomatic vertebral fracture RR 0.49 (0.14 to 1.74) and other fractures RR 0.78 (0.42 to 1.45), all very low certainty and up to two years. Bisphosphonates probably did not increase adverse or serious adverse events. Results were similarly uncertain for the other agents.
This does not mean these drugs fail in men. Trials in men were designed around bone density, not fractures, and were too small and short to show fracture benefit. Treatment in men currently rests largely on extrapolation from women.
- Continue to assess fracture risk in men after a fragility fracture.
- Explain to patients that fracture-benefit evidence in men is indirect.
- Bisphosphonates were not associated with more adverse events.
- Share decisions, and recheck adherence at follow-up.
Why it matters
It exposes how little direct fracture evidence underpins osteoporosis treatment in men.
Don't overread it
Uncertain evidence of benefit is not evidence of no benefit — the trials were too small to tell.
The statistics, in plain English
An interval from 0.06 to 8.51 means the data fit anything from a 94% reduction to an eight-fold increase — in other words, they cannot answer the question. That reflects very few hip fractures (4 in total), not a failed drug.
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