The Effect of a Screening and Treatment Program for the Prevention of Fractures in Older Women: A Randomized Pragmatic Trial

The Effect of a Screening and Treatment Program for the Prevention of Fractures in Older Women: A Randomized Pragmatic Trial
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DOI:
10.1002/jbmr.3815
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发表时间:
2019-08-01
影响因子:
6.2
通讯作者:
Elders, Petra J. M.
Elders, Petra J. M.
中科院分区:
医学1区
文献类型:
--
作者:
Merlijn, Thomas;Swart, Karin M. A.;Elders, Petra J. M.

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对人群进行骨折风险筛查可降低骨折发生率。在这项随机实用性试验中,SALT骨质疏松研究(SOS),我们研究了与常规护理相比,在初级护理中筛查骨折风险和随后的治疗是否可以减少骨折。共有11,032名年龄在65至90岁之间,具有≥ 1个骨折临床危险因素的女性被随机分为筛查组(n = 5575)和常规护理组(n = 5457)。筛查组的参与者接受了筛查计划,包括骨密度测定和椎骨骨折评估。具有高10年骨折概率(FRAX)或椎骨骨折的参与者由他们的全科医生提供抗骨质疏松药物治疗。调查问卷报告的骨折事件与病历进行了验证。94%的参与者完成了随访(平均随访时间= 3.7年)。在筛选组的5575名参与者中,1417名(25.4%)有抗骨质疏松药物的适应症。筛选和后续治疗对主要结局骨折无统计学显著影响(风险比[HR] = 0.97; 95%置信区间[CI] 0.87-1.08),也不影响继发性骨折结局(HR = 0.91; 95% CI 0.81-1.03),严重椎体骨折(HR = 0.91; 95% CI 0.80-1.04),髋部骨折(HR = 0.91; 95% CI 0.71-1.15)、福尔斯(比值比[OR] = 0.91; 95% CI 0.72-1.15)或死亡(HR = 1.03; 95% CI 0.91-1.17)。事后探索性发现表明,在近期骨折后进行筛查可能最有效(严重腰椎骨折的HR = 0.65; 95% CI 0.44-0.96,髋部骨折的HR = 0.38; 95% CI 0.18-0.79)。本研究的结果可能受到筛选组中未参与和未依从药物的影响。总的来说,这项研究没有提供足够的迹象,考虑筛选骨折预防。然而,我们不能排除其临床意义,以减少(主要)骨质疏松性骨折和髋部骨折,因为相对较少的妇女在干预组的治疗适应症。(c)2019年,任作家。骨与矿物质研究杂志由Wiley Periodicals,Inc.出版。
Population screening for fracture risk may reduce the fracture incidence. In this randomized pragmatic trial, the SALT Osteoporosis Study (SOS), we studied whether screening for fracture risk and subsequent treatment in primary care can reduce fractures compared with usual care. A total of 11,032 women aged 65 to 90 years with >= 1 clinical risk factor for fractures were individually randomized to screening (n = 5575) or usual care (n = 5457). Participants in the screening group underwent a screening program, including bone densitometry and vertebral fracture assessment. Participants with a high 10-year fracture probability (FRAX) or a vertebral fracture were offered treatment with anti-osteoporosis medication by their general practitioner. Incident fractures as reported by questionnaires were verified with medical records. Follow-up was completed by 94% of the participants (mean follow-up = 3.7 years). Of the 5575 participants in the screening group, 1417 (25.4%) had an indication for anti-osteoporosis medication. Screening and subsequent treatment had no statistically significant effect on the primary outcome fracture (hazard ratio [HR] = 0.97; 95% confidence interval [CI] 0.87-1.08), nor on the secondary outcomes osteoporotic fractures (HR = 0.91; 95% CI 0.81-1.03), major osteoporotic fractures (HR = 0.91; 95% CI 0.80-1.04), hip fractures (HR = 0.91; 95% CI 0.71-1.15), falls (odds ratio [OR] = 0.91; 95% CI 0.72-1.15), or mortality (HR = 1.03; 95% CI 0.91-1.17). Post hoc explorative finding suggested that screening might be most effective after a recent fracture (HR = 0.65; 95% CI 0.44-0.96 for major osteoporotic fractures and HR = 0.38; 95% CI 0.18-0.79 for hip fractures). The results of this study might have been compromised by nonparticipation and medication nonadherence in the screening group. Overall, this study does not provide sufficient indications to consider screening for fracture prevention. However, we cannot exclude its clinical relevance to reduce (major) osteoporotic fractures and hip fractures because of the relatively small number of women with a treatment indication in the intervention group. (c) 2019 The Authors. Journal of Bone and Mineral Research Published by Wiley Periodicals, Inc.