Department of Clinical Gerontology, Robert-Bosch-Hospital, Auerbachstr. 110, 70376, Stuttgart, Germany.
College of Medicine and Health, St Lukes Campus, University of Exeter, Exeter, EX12LU, UK.
BMC Med. 2022 Feb 4;20(1):49. doi: 10.1186/s12916-021-02226-8.
Fractures 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.
This 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).
Nine 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.
A 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.
German Clinical Trials Register DRKS-ID: 00009000.
骨折是老龄化社会的一个主要健康问题。将骨骼健康与防跌倒结合起来的预防措施很少见。农村地区骨质疏松性骨折预防计划（OFRA）是德国随机选择的地区为老年人提供的一项医疗保险驱动的计划。该计划的组成部分包括防跌倒运动课程、双能 X 射线吸收法（DXA）扫描检查骨骼健康状况，以及关于“生活环境安全”的咨询。本研究的目的是在常规医疗保健环境中评估这种复杂的预防干预措施。
这项集群随机试验于 2015 年 10 月至 2018 年 10 月进行，在德国五个联邦州的 186 个行政区进行，47 个行政区为干预区，139 个为对照区。在这些行政区内，我们纳入了：（a）所有 70-85 岁有脆性骨折既往史的社区居住的女性和男性；（b）所有 75-80 岁的社区居住的女性。分析使用了一家医疗保险公司收集的常规数据。主要终点是所有脆性骨折的综合情况。骨折类型、死亡率和疗养院入院是探索性终点。使用 Cox 脆弱性模型进行比较分析，中位随访时间为 365 天（四分位间距：0 天）。
有 9408 人被邀请参加该计划的一个组成部分，有 27318 人作为对照组。平均年龄为 78.7 岁。在被邀请参加的人中，近 30%的人参加了运动课程。DXA 测量费用得到了 13.6%的报销，51.8%的人获得了关于增加“生活环境安全”措施的建议。干预组和对照组的脆性骨折发生率没有差异（HR 0.94；95%CI 0.80-1.11）。然而，干预组股骨骨折（最常见的骨折类型）减少（HR 0.76；95%CI 0.59-0.99）。干预组和对照组的死亡率和疗养院入院率没有差异。
为农村地区的老年人实施了一项全面的骨折预防计划。该计划并未影响所有脆性骨折综合的主要终点。需要考虑的是，我们根据地理随机化和终点信息使用了修改后的意向治疗方法，仅依赖于医疗保险的常规数据。
德国临床试验注册处 DRKS-ID：00009000。
