Effect of an osteoporotic fracture prevention program on fracture incidence in routine care: a cluster-randomized trial

BMC Medicine

Sarah E. Lamb¹  Kilian Rapp²  Clemens Becker²  Patrick Roigk²  Hans-Helmut König³  Claudia Konnopka³  Raphael S. Peter⁴  Gisela Büchele⁴  Dietrich Rothenbacher⁴ 

[1] College of Medicine and Health, St Lukes Campus, University of Exeter, EX12LU, Exeter, UK;Department of Clinical Gerontology, Robert-Bosch-Hospital, Auerbachstr. 110, 70376, Stuttgart, Germany;Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany;Institute of Epidemiology and Medical Biometry, Ulm University, Helmholtzstr. 22, 89081, Ulm, Germany;

关键词: Falls;    Osteoporotic fractures;    Prevention;    Rural area;    Mobility and falls prevention exercise classes;    DXA;   

DOI  :  10.1186/s12916-021-02226-8

来源: Springer

【 摘 要 】

BackgroundFractures are a major health problem in aging societies. Preventive approaches combining bone health and fall prevention are rare. The osteoporotic fracture prevention program in rural areas (OFRA) is a health care fund-driven program for older people in randomly selected districts in Germany. The components of the program were falls prevention exercise classes, examination of bone health by a dual-energy X-ray absorptiometry (DXA) scan, and a consultation about “safety in the living environment.” The aim of this study was to evaluate this complex preventive intervention in a routine health care setting.MethodsThis cluster-randomized trial was performed from October 2015 to October 2018 and took place in 186 administrative districts in five federal states, 47 districts served as intervention districts, and 139, as controls. Within these districts, we included (a) all community-living women and men aged 70–85 years with prior fragility fractures and (b) all community-living women aged 75–80 years. The analysis used routine data collected by a health insurance company. The primary endpoint was all fragility fractures combined. Fracture types, mortality, and nursing home admission were explorative endpoints. Cox frailty models were used for comparative analyses with a median follow-up time of 365 days (interquartile range: 0 days).ResultsNine thousand four hundred eight individuals were approached to participate in one of the program components, 27,318 individuals served as controls. The mean age was 78.7 years. Of those approached to participate, nearly 30% joined the exercise classes. DXA measurement was reimbursed for 13.6%, and 51.8% received advice about measures to increase “safety in the living environment.” The incidence of fragility fractures did not differ between the intervention and the control group (HR 0.94; 95% CI 0.80–1.11). However, femoral fractures, the most frequent fracture type, were reduced in the intervention group (HR 0.76; 95% CI 0.59–0.99). Mortality and nursing home admission did not differ between the intervention and the control group.ConclusionsA comprehensive fracture prevention program for older people living in rural areas was implemented. The program did not affect the primary endpoint of all fragility fractures combined. It has to be considered that we used a modified intention to treat approach based on geographic randomization and information about endpoints relied exclusively on routine data of the health care insurance.Trial registrationGerman Clinical Trials Register DRKS-ID: 00009000

【 授权许可】

CC BY