S Palacios1, L Kalouche-Khalil2, R Rizzoli3, C Zapalowski4, H Resch5, J D Adachi6, J C Gallagher7, R G Feldman8, D L Kendler9, A Wang4, R B Wagman4, S Adami10. 1. a * Institute of Women's Health , Madrid , Spain. 2. b Amgen (Europe) GmbH , Zug , Switzerland. 3. c Geneva University Hospitals, Faculty of Medicine , Geneva , Switzerland. 4. d Amgen Inc. , Thousand Oaks , CA , USA. 5. e St Vincent Hospital , Vienna , Austria. 6. f St Joseph's Healthcare, McMaster University , Hamilton , ON , Canada. 7. g Creighton University Medical School , Omaha , NE , USA. 8. h Senior Clinical Trials Inc. , Laguna Hills , CA , USA. 9. i University of British Columbia , Vancouver , BC , Canada. 10. j University of Verona , Verona , Italy.
Abstract
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.
RCT Entities:
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.
Authors: N C W Harvey; E V McCloskey; P J Mitchell; B Dawson-Hughes; D D Pierroz; J-Y Reginster; R Rizzoli; C Cooper; J A Kanis Journal: Osteoporos Int Date: 2017-02-07 Impact factor: 4.507
Authors: Olga Růžičková; Zdenko Killinger; Petr Kasalický; Lisa Hamilton; Roman Tyl; Soňa Tomková; Lama Kalouche-Khalil Journal: Adv Ther Date: 2018-09-06 Impact factor: 3.845
Authors: M K Skjødt; S Khalid; M Ernst; K H Rubin; D Martinez-Laguna; A Delmestri; M K Javaid; C Cooper; C Libanati; E Toth; B Abrahamsen; D Prieto-Alhambra Journal: Osteoporos Int Date: 2020-03-17 Impact factor: 4.507