Treatment with denosumab reduces secondary fracture risk in women with postmenopausal osteoporosis

S. Palacios, L. Kalouche-Khalil, R. Rizzoli, C. Zapalowski, H. Resch, J. D. Adachi, John Christopher G. Gallagher, R. G. Feldman, D. L. Kendler, A. Wang, R. B. Wagman, S. Adami

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8 Scopus citations


A history of prior fracture is one of the strongest predictors of a future fragility fracture. In FREEDOM, denosumab significantly reduced the risk of new vertebral, non-vertebral, and hip fractures. We carried out a post-hoc analysis of FREEDOM to characterize the efficacy of denosumab in preventing secondary fragility fractures in subjects with a prior fracture.Methods A total of 7808 women aged 60-90 years with a bone mineral density T-score of less than-2.5 but not less than-4.0 at either the lumbar spine or total hip were randomized to subcutaneous denosumab 60 mg or placebo every 6 months for 36 months. The anti-fracture efficacy of denosumab was analyzed by prior fracture status, to assess secondary fragility fracture, and by subject age, prior fracture site and history of prior osteoporosis medication use.Results A prior fragility fracture was reported for 45% of the overall study population. Compared with placebo, denosumab significantly reduced the risk of a secondary fragility fracture by 39% (incidence, 17.3% vs. 10.5%; p <0.0001). Similar results were observed regardless of age or prior fracture site. In the overall population, denosumab significantly reduced the risk of a fragility fracture by 40% (13.3% vs. 8.0%; p <0.0001), with similar results observed regardless of history of prior osteoporotic medication use.Conclusions Denosumab reduced the risk of fragility fractures to a similar degree in all risk subgroups examined, including those with prior fragility fractures. Identifying and treating high-risk individuals could help to close the current care gap in secondary fracture prevention.

Original languageEnglish
Pages (from-to)805-812
Number of pages8
Issue number6
Publication statusPublished - Nov 2 2015


All Science Journal Classification (ASJC) codes

  • Obstetrics and Gynecology

Cite this

Palacios, S., Kalouche-Khalil, L., Rizzoli, R., Zapalowski, C., Resch, H., Adachi, J. D., ... Adami, S. (2015). Treatment with denosumab reduces secondary fracture risk in women with postmenopausal osteoporosis. Climacteric, 18(6), 805-812.