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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, J C; Feldman, R G; Kendler, D L; Wang, A; Wagman, R B; Adami, S.
Afiliación
  • Palacios S; a * Institute of Women's Health , Madrid , Spain.
  • Kalouche-Khalil L; b Amgen (Europe) GmbH , Zug , Switzerland.
  • Rizzoli R; c Geneva University Hospitals, Faculty of Medicine , Geneva , Switzerland.
  • Zapalowski C; d Amgen Inc. , Thousand Oaks , CA , USA.
  • Resch H; e St Vincent Hospital , Vienna , Austria.
  • Adachi JD; f St Joseph's Healthcare, McMaster University , Hamilton , ON , Canada.
  • Gallagher JC; g Creighton University Medical School , Omaha , NE , USA.
  • Feldman RG; h Senior Clinical Trials Inc. , Laguna Hills , CA , USA.
  • Kendler DL; i University of British Columbia , Vancouver , BC , Canada.
  • Wang A; d Amgen Inc. , Thousand Oaks , CA , USA.
  • Wagman RB; d Amgen Inc. , Thousand Oaks , CA , USA.
  • Adami S; j University of Verona , Verona , Italy.
Climacteric ; 18(6): 805-12, 2015.
Article en En | MEDLINE | ID: mdl-26029985
OBJECTIVES: 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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Fracturas de la Columna Vertebral / Conservadores de la Densidad Ósea / Denosumab / Fracturas de Cadera / Vértebras Lumbares Tipo de estudio: Clinical_trials / Etiology_studies / Incidence_studies / Prognostic_studies / Risk_factors_studies Límite: Aged / Aged80 / Female / Humans / Middle aged Idioma: En Revista: Climacteric Asunto de la revista: GINECOLOGIA Año: 2015 Tipo del documento: Article País de afiliación: España Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Fracturas de la Columna Vertebral / Conservadores de la Densidad Ósea / Denosumab / Fracturas de Cadera / Vértebras Lumbares Tipo de estudio: Clinical_trials / Etiology_studies / Incidence_studies / Prognostic_studies / Risk_factors_studies Límite: Aged / Aged80 / Female / Humans / Middle aged Idioma: En Revista: Climacteric Asunto de la revista: GINECOLOGIA Año: 2015 Tipo del documento: Article País de afiliación: España Pais de publicación: Reino Unido