Horm Metab Res 2009; 41(10): 721-729
DOI: 10.1055/s-0029-1224109

© Georg Thieme Verlag KG Stuttgart · New York

Efficacy and Safety of Denosumab in Postmenopausal Women with Osteopenia or Osteoporosis: A Systematic Review and a Meta-analysis

A. D. Anastasilakis1 , K. A. Toulis1 , D. G. Goulis2 , S. A. Polyzos3 , S. Delaroudis1 , A. Giomisi4 , E. Terpos5
  • 1Department of Endocrinology, 424 Military Hospital, Thessaloniki, Greece
  • 2Unit of Reproductive Endocrinology, First Department of Obstetrics and Gynecology, Aristotle University of Thessaloniki, Greece
  • 3Second Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece
  • 4Department of Obstetrics-Gynaecology, 424 Military Hospital, Thessaloniki, Greece
  • 5Department of Medical Research, 251 General Air Force Hospital, Athens, Greece
Further Information

Publication History

received 26.03.2009

accepted 17.04.2009

Publication Date:
17 June 2009 (online)


Receptor activator of nuclear factor-κB ligand (RANKL) is a cytokine essential for osteoclast differentiation, activation, and survival. Denosumab, a human monoclonal antibody against RANKL, constitutes a promising antiresorptive agent for osteoporosis. We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), and other trial registries through January 2009. We selected randomized controlled trials (RCTs) of denosumab in women with low bone mass that described the changes on bone markers and bone mineral density (BMD) as well as the adverse events including fracture risk. We analyzed data from nine RCTs involving 10 329 participants. Although denosumab universally decreased bone markers and increased lumbar and hip BMD, the efficacy evaluation based on percentage (%) mean change from the baseline was not possible due to missing data. Denosumab was not associated with a significant reduction in fracture risk [OR (95% CI) 0.74 (0.33 to 1.64), p=0.45]. Increased risk of serious adverse events [OR (95% CI) 1.83 (1.10 to 3.04), p=0.02] and serious infections [OR (95% CI) 4.45 (1.15 to 17.14), p=0.03] were evident. In conclusion, although effective as an antiresorptive agent, denosumab has not yet proved its efficacy on fracture risk reduction while increased infection risk questions its safety.



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