The Bone, Exercise, Alendronate, and Caloric Restriction (BEACON) trial design and methods

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary clinical trials Pub Date : 2024-09-17 DOI:10.1016/j.cct.2024.107692

Kristen M. Beavers , Brianna R. Wolle , Jamy D. Ard , Daniel P. Beavers , Olivia Biehl , Peter H. Brubaker , Andrew J. Burghardt , Christa T. Calderone , Julio Carballido-Gamio , Jason Fanning , Wendy M. Kohrt , Monica Love , Catherine M. MacLean , Barbara J. Nicklas , Joshua Stapleton , Christine M. Swanson , Ashley A. Weaver , Marcelina Worden , Sarah J. Wherry

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Abstract

Background

Among older adults living with obesity, intentional weight loss (WL) improves prognosis of many comorbidities. However, concomitant decline in bone mineral density (BMD) limits overall benefit of WL by increasing osteoporotic fracture risk. Identification of intervention strategies to maximize body fat loss, while minimizing harm to the musculoskeletal system, is an important area of clinical research. The main objective of the Bone, Exercise, Alendronate, and Caloric Restriction (BEACON) trial (NCT05764733) is to compare the independent and combined effects of a 12-month intervention of resistance training (RT) plus bone-loading exercises and bisphosphonate use on dietary WL-associated bone loss among 308 older (≥60 years) adults living with an indication for WL and bisphosphonate use.

Methods

All participants will receive the same group-mediated dietary intervention targeting 8–10 % WL and be randomized to one of four groups: no RT and placebo capsules (NoRT+PL); progressive RT plus bone-loading exercises and placebo capsules (RT⁺+PL); no RT and oral bisphosphonate (70 mg weekly oral alendronate; NoRT+BIS); or progressive RT plus bone-loading exercises and oral bisphosphonate (RT⁺+BIS). Total hip areal (a)BMD measured via dual-energy x-ray absorptiometry (DXA) is the primary, powered study outcome. Secondary skeletal outcome measures include femoral neck and lumbar spine aBMD, high resolution peripheral quantitative computed tomography (HRpQCT) bone assessments of the radius and tibia, and biomarkers of bone turnover.

Discussion

BEACON will address an understudied, yet important, clinical research question by studying the independent and combined effects of two scalable intervention strategies aimed at optimizing skeletal integrity in older adults undergoing WL.

Clinical Trials Registration: NCT05764733

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骨骼、运动、阿仑膦酸盐和热量限制（BEACON）试验的设计和方法

背景在患有肥胖症的老年人中，有意减轻体重（WL）可改善许多合并症的预后。然而，伴随而来的骨质密度（BMD）下降会增加骨质疏松性骨折的风险，从而限制了减重的整体效益。确定干预策略以最大限度地减少体内脂肪，同时最大限度地减少对肌肉骨骼系统的伤害，是临床研究的一个重要领域。骨质、运动、阿仑膦酸盐和热量限制（BEACON）试验（NCT05764733）的主要目的是比较为期 12 个月的阻力训练（RT）加骨质加载运动干预和使用双膦酸盐对 308 名有 WL 适应症和使用双膦酸盐的老年人（≥60 岁）饮食 WL 相关骨质流失的独立和综合影响。方法所有参与者都将接受以 8-10% WL 为目标的同一组饮食干预，并随机分为四组：无 RT 和安慰剂胶囊组（NoRT+PL）；渐进 RT 加骨质疏松锻炼和安慰剂胶囊组（RT++PL）；无 RT 和口服双膦酸盐组（每周口服 70 毫克阿仑膦酸盐；NoRT+BIS）；或渐进 RT 加骨质疏松锻炼和口服双膦酸盐组（RT++BIS）。通过双能 X 射线吸收测定法（DXA）测量的总髋关节(a)BMD 是主要的研究结果。讨论BEACON将通过研究旨在优化接受WL治疗的老年人骨骼完整性的两种可扩展干预策略的独立效果和联合效果，解决一个未得到充分研究但却非常重要的临床研究问题：临床试验注册：NCT05764733

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.