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针对高危男性骨质疏松症筛查的远程骨骼健康服务:一项整群随机临床试验

Remote Bone Health Service for Osteoporosis Screening in High-Risk Men: A Cluster Randomized Clinical Trial.

作者信息

Colón-Emeric Cathleen, Lee Richard, Lyles Kenneth W, Zullig Leah L, Sloane Richard, Pieper Carl F, Nelson Richard E, Adler Robert A

机构信息

Geriatrics Research Education and Clinical Center and Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health System, Durham, North Carolina.

Duke University School of Medicine, Durham, North Carolina.

出版信息

JAMA Intern Med. 2025 Aug 25. doi: 10.1001/jamainternmed.2025.4150.

Abstract

IMPORTANCE

Evidence supporting osteoporosis screening in men is limited. Efficient models that promote osteoporosis screening and adherence in primary care are needed.

OBJECTIVE

To test the impact of a centralized, remote bone health service (BHS) on screening, treatment, adherence, and bone density in older men with fracture risk factors.

DESIGN, SETTING, AND PARTICIPANTS: This cluster randomized clinical trial involved 39 primary care teams in 2 Veterans Affairs (VA) Health Systems that included 3112 male veterans aged 65 to 85 years who had at least 1 fracture risk factor but had no prior fractures. Data were analyzed from July through November 2025.

INTERVENTION

Eligible men in medical teams randomized to BHS were invited to undergo dual-energy x-ray absorptiometry (DXA) scan, followed by an electronic consult to their primary care clinician with additional recommendations. A nurse care manager entered orders, obtained test results, provided patient education, and monitored adherence over the phone. Primary care teams randomized to usual care received osteoporosis education and VA practice guidelines.

MAIN OUTCOMES AND MEASURES

DXA screening rates, osteoporosis treatment, persistence, and adherence were compared between patients in BHS and usual care. A random subset of patients in each team had a DXA 24 months after team enrollment, regardless of whether they had been screened during the intervention.

RESULTS

Of the 3112 randomized participants (mean [SD] age, 73.3 [5.3] years; 1260 [40.4%] were Black; and 1748 [56%] were White), 49.2% (830 of 1688) in the BHS group were screened vs 2.3% (33 of 1424) in the usual care group (P < .001). More than half of those screened (441 [51.1%]) had osteopenia or osteoporosis. One hundred fifty-seven patients (84.4%) in the BHS group initiated osteoporosis treatment and achieved high levels of adherence with a mean of 91.7% of subsequent days covered and a high persistence with a mean 657 (SD, 366) days over 2 years of follow-up. The mean femoral neck T-score 2 years after team initiation in a random subset favored BHS vs usual care (-0.55 vs -0.70, P = .04).

CONCLUSIONS AND RELEVANCE

This cluster randomized clinical trial found that the BHS model was associated with significantly improved osteoporosis screening, treatment, and adherence compared with usual care, with high patient and clinician acceptance. Selecting men for osteoporosis screening based on clinical risk factors before a fracture has occurred has a high screening yield. This approach requires validation in other clinical settings and with longer follow-up to determine impact on fractures.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT04079868.

摘要

重要性

支持男性骨质疏松症筛查的证据有限。需要有效的模型来促进初级保健中骨质疏松症的筛查和依从性。

目的

测试集中式远程骨骼健康服务(BHS)对有骨折风险因素的老年男性的筛查、治疗、依从性和骨密度的影响。

设计、设置和参与者:这项整群随机临床试验涉及2个退伍军人事务(VA)医疗系统中的39个初级保健团队,包括3112名年龄在65至85岁之间、至少有1个骨折风险因素但既往无骨折的男性退伍军人。数据于2025年7月至11月进行分析。

干预措施

随机分配到BHS的医疗团队中的符合条件的男性被邀请接受双能X线吸收法(DXA)扫描,随后通过电子会诊向其初级保健临床医生提供额外建议。一名护士护理经理下达医嘱、获取检测结果、提供患者教育并通过电话监测依从性。随机分配到常规护理的初级保健团队接受骨质疏松症教育和VA实践指南。

主要结局和指标

比较BHS组和常规护理组患者的DXA筛查率、骨质疏松症治疗、持续性和依从性。每个团队中随机抽取的一部分患者在团队入组24个月后进行DXA检查,无论他们在干预期间是否接受过筛查。

结果

在3112名随机参与者中(平均[标准差]年龄为73.3[5.3]岁;1260名[40.4%]为黑人;1748名[56%]为白人),BHS组中有49.2%(1688名中的830名)接受了筛查,而常规护理组为2.3%(1424名中的33名)(P < .001)。超过一半接受筛查的患者(441名[51.1%])患有骨量减少或骨质疏松症。BHS组中有157名患者(84.4%)开始接受骨质疏松症治疗,并实现了高依从性,后续平均覆盖天数为91.7%,在2年随访期间平均持续657(标准差,366)天,持续性较高。在随机抽取的一部分患者中,团队启动2年后的平均股骨颈T值,BHS组优于常规护理组(-0.55对-0.70,P = .04)。

结论和相关性

这项整群随机临床试验发现,与常规护理相比,BHS模型与骨质疏松症筛查、治疗和依从性的显著改善相关,患者和临床医生接受度高。在骨折发生前根据临床风险因素选择男性进行骨质疏松症筛查具有很高的筛查收益。这种方法需要在其他临床环境中进行验证,并进行更长时间的随访以确定对骨折的影响。

试验注册

ClinicalTrials.gov标识符:NCT04079868。

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Evidence-Based Guideline for the management of osteoporosis in men.男性骨质疏松症管理的循证指南。
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