Clinical efficacy and safety of denosumab in postmenopausal women with low bone mineral density and osteoporosis: a meta-analysis.

OBJECTIVE

Clinical trials indicate that denosumab could be a potential treatment for postmenopausal osteoporosis. The objective of this meta-analysis was to assess the clinical efficacy and safety of offering denosumab to postmenopausal women with low bone mass.

METHODS

Data sources included MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) from inception to February 3, 2010 and bibliographies of reviews. Randomized controlled trials comparing the efficacy and safety of denosumab to placebo for treatment of low bone mass (low bone mineral density or osteoporosis) in postmenopausal women were selected. Two reviewers independently abstracted data on study general characteristics and outcomes. Review Manager 5.0 software was used for data syntheses and meta-analysis.

RESULTS

The database search revealed 4 studies (comprising 8864 patients randomized) that met the inclusion criteria and contributed to some or all of the meta-analysis outcomes. Relative risk (95% CI) of fractures for the denosumab compared with placebo group was 0.58 (0.52 to 0.66); relative risk (95% CI) of serious adverse events was 1.33 (0.83 to 2.14); relative risk (95% CI) of serious adverse events related to infection was 2.10 (0.64 to 6.90); relative risk (95% CI) of neoplasm was 1.11 (0.91 to 1.36); relative risk (95% CI) of study discontinuation due to adverse events was 1.10 (0.83 to 1.47); and relative risk (95% CI) of death was 0.78 (0.57 to 1.06). Findings remained robust to sensitivity analyses.

CONCLUSION

Our analysis found a significant reduction in relative fracture risk in the denosumab compared with the placebo group.