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

Research output: Contribution to journalArticle

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Abstract

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
JournalClimacteric
Volume18
Issue number6
DOIs
StatePublished - Nov 2 2015

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Postmenopausal Osteoporosis
Therapeutics
Placebos
Hip Fractures
Secondary Prevention
Denosumab
Bone Density
Population
Osteoporosis
Hip
Spine
Incidence

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. https://doi.org/10.3109/13697137.2015.1045484

Treatment with denosumab reduces secondary fracture risk in women with postmenopausal osteoporosis. / Palacios, S.; Kalouche-Khalil, L.; Rizzoli, R.; Zapalowski, C.; Resch, H.; Adachi, J. D.; Gallagher, John Christopher G.; Feldman, R. G.; Kendler, D. L.; Wang, A.; Wagman, R. B.; Adami, S.

In: Climacteric, Vol. 18, No. 6, 02.11.2015, p. 805-812.

Research output: Contribution to journalArticle

Palacios, S, Kalouche-Khalil, L, Rizzoli, R, Zapalowski, C, Resch, H, Adachi, JD, Gallagher, JCG, Feldman, RG, Kendler, DL, Wang, A, Wagman, RB & Adami, S 2015, 'Treatment with denosumab reduces secondary fracture risk in women with postmenopausal osteoporosis', Climacteric, vol. 18, no. 6, pp. 805-812. https://doi.org/10.3109/13697137.2015.1045484
Palacios S, Kalouche-Khalil L, Rizzoli R, Zapalowski C, Resch H, Adachi JD et al. Treatment with denosumab reduces secondary fracture risk in women with postmenopausal osteoporosis. Climacteric. 2015 Nov 2;18(6):805-812. https://doi.org/10.3109/13697137.2015.1045484
Palacios, S. ; Kalouche-Khalil, L. ; Rizzoli, R. ; Zapalowski, C. ; Resch, H. ; Adachi, J. D. ; Gallagher, John Christopher G. ; Feldman, R. G. ; Kendler, D. L. ; Wang, A. ; Wagman, R. B. ; Adami, S. / Treatment with denosumab reduces secondary fracture risk in women with postmenopausal osteoporosis. In: Climacteric. 2015 ; Vol. 18, No. 6. pp. 805-812.
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abstract = "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.",
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AU - Resch, H.

AU - Adachi, J. D.

AU - Gallagher, John Christopher G.

AU - Feldman, R. G.

AU - Kendler, D. L.

AU - Wang, A.

AU - Wagman, R. B.

AU - Adami, S.

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N2 - 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.

AB - 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.

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