Four RCTs (8,864 participants) were included in the review and meta-analysis; study sample size ranged from 252 to 7,868 participants. Trials scored 3 (one trial), 4 (two trials) and the maximum score of 5 (one trial) for quality with the Jadad Scale.
Fracture risk was statistically significantly lower for postmenopausal women in the denosumab group, compared with the placebo group (RR 0.58, 95% CI 0.52 to 0.66, Ι²=15%, three trials).
No statistically significant differences between denosumab and placebo groups were found for risk of serious adverse events, serious adverse events related to infection, neoplasm, study discontinuation due to adverse events, and mortality (reported fully in the paper).
Sensitivity analyses revealed statistically similar findings for all of the outcomes (reported fully in the paper).