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 language | English |
|---|---|
| Pages (from-to) | 805-812 |
| Number of pages | 8 |
| Journal | Climacteric |
| Volume | 18 |
| Issue number | 6 |
| DOIs | |
| State | Published - Nov 2 2015 |
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All Science Journal Classification (ASJC) codes
- Obstetrics and Gynecology
Cite this
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 journal › Article
}
TY - JOUR
T1 - Treatment with denosumab reduces secondary fracture risk in women with postmenopausal osteoporosis
AU - Palacios, S.
AU - Kalouche-Khalil, L.
AU - Rizzoli, R.
AU - Zapalowski, C.
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.
PY - 2015/11/2
Y1 - 2015/11/2
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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U2 - 10.3109/13697137.2015.1045484
DO - 10.3109/13697137.2015.1045484
M3 - Article
VL - 18
SP - 805
EP - 812
JO - Climacteric
JF - Climacteric
SN - 1369-7137
IS - 6
ER -