Comparison of Risk of Osteoporotic Fracture in Denosumab vs Alendronate Treatment Within 3 Years of Initiation
Pedersen, Alma B. (Aarhus University Hospital (Aarhus, Dinamarca))
Heide-Jørgensen, Uffe (Aarhus University Hospital (Aarhus, Dinamarca))
Sørensen, Henrik T. (Aarhus University Hospital (Aarhus, Dinamarca))
Prieto-Alhambra, Daniel (Universitat Autònoma de Barcelona)
Ehrenstein, Vera (Aarhus University Hospital (Aarhus, Dinamarca))

Data:	2019
Resum:	What is the real-world risk of fracture for patients treated with denosumab compared with those treated with alendronate? In this Danish cohort study including 4624 individuals treated with denosumab and 87 731 individuals treated with alendronate, 3-year cumulative incidence of hip fracture was 3. 7% and 3. 1% among the denosumab and alendronate cohorts, respectively. The 3-year cumulative incidence of any fracture was 9. 0% for both cohorts. In routine clinical practice, initiation of denosumab and alendronate treatments were associated with similar risks of hip and any fracture over a 3-year period. This cohort study of individually linked data from Danish health registries compares the risk of hip and any fracture in adult patients treated with denosumab vs alendronate in routine practice settings. Head-to-head randomized clinical trials showed greater efficacy of denosumab vs alendronate in improving bone mineral density. Although there is an association of changes in bone mineral density with reductions in fracture risk, the magnitude of the association is not well established. To compare the risk of hip and any fracture in patients treated with denosumab and alendronate in routine practice settings. This Danish nationwide, population-based, historical cohort study of a population with universal access to health care used prospectively collected, individually linked data from Danish health registries with complete follow-up. Cohorts consisted of 92 355 individuals 50 years or older who were new users of denosumab (n = 4624) or alendronate (n = 87 731) from May 2010 to December 2017 after at least 1 year without an antiosteoporosis medication dispensing. Initiation of denosumab or alendronate. The primary outcome was hospitalization for hip fracture, and the secondary outcome was hospitalization for any fracture. Inverse probability of treatment weights and the intention-to-treat approach were used to calculate cumulative incidences and adjusted hazard ratios (aHRs) with 95% CIs. Of the 92 355 included patients, 75 046 (81. 3%) were women, and the mean (SD) age was 71 (10) years. The denosumab cohort had a lower proportion of men than the alendronate cohort (12. 7% [589] vs 19. 0% [16 700]), while age distributions were similar in the 2 cohorts. Within 3 years of follow-up, initiation of denosumab or alendronate was associated with cumulative incidences of 3. 7% and 3. 1%, respectively, for hip fracture and 9. 0% and 9. 0%, respectively, for any fracture. Overall, the aHRs for denosumab vs alendronate were 1. 08 (95% CI, 0. 92-1. 28) for hip fracture and 0. 92 (95% CI, 0. 83-1. 02) for any fracture. The aHR of denosumab vs alendronate for hip fracture was 1. 07 (95% CI, 0. 85-1. 34) among patients with a history of any fracture and 1. 05 (95% CI, 0. 83-1. 32) among patients without history of fracture. The aHR for any fracture for denosumab vs alendronate was 0. 84 (95% CI, 0. 71-0. 98) among patients with a history of any fracture and 0. 77 (95% CI, 0. 64-0. 93) among patients with no history of fracture. Treatment with denosumab and alendronate was associated with similar risks of hip or any fracture over a 3-year period, regardless of fracture history.
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Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	JAMA network open, Vol. 2 (april 2019) , ISSN 2574-3805

DOI: 10.1001/jamanetworkopen.2019.2416
PMID: 31002319

11 p, 902.4 KB

El registre apareix a les col·leccions:
Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
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