Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA.
Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA.
Contemp Clin Trials. 2024 Nov;146:107692. doi: 10.1016/j.cct.2024.107692. Epub 2024 Sep 17.
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.
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.
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.
NCT05764733.
在患有肥胖症的老年人中，有目的的体重减轻（WL）可改善许多合并症的预后。然而，由于骨密度（BMD）的同时下降，增加了骨质疏松性骨折的风险，从而限制了 WL 的总体益处。寻找最大限度地减少体脂减少，同时最大限度地减少对肌肉骨骼系统的伤害的干预策略是临床研究的重要领域。Bone、Exercise、Alendronate 和 Caloric Restriction（BEACON）试验（NCT05764733）的主要目的是比较为期 12 个月的干预措施的独立和联合作用，该干预措施包括抗阻力训练（RT）加骨负荷运动和使用双膦酸盐，以比较 308 名患有 WL 和需要使用双膦酸盐的老年人（≥60 岁）的饮食 WL 相关骨丢失，其中包括抗阻力训练（RT）加骨负荷运动和使用双膦酸盐的老年人（≥60 岁）。
所有参与者都将接受相同的团体介导的饮食干预，目标是减轻 8-10%的体重，并随机分为四组之一：无 RT 和安慰剂胶囊（NoRT+PL）；逐渐增加 RT 加骨负荷运动和安慰剂胶囊（RT+PL）；无 RT 和口服双膦酸盐（每周 70 毫克口服阿仑膦酸钠；NoRT+BIS）；或逐渐增加 RT 加骨负荷运动和口服双膦酸盐（RT+BIS）。通过双能 X 射线吸收法（DXA）测量的全髋关节面积（a）BMD 是主要的、有力量的研究结果。次要骨骼结局测量包括股骨颈和腰椎 aBMD、高分辨率外周定量计算机断层扫描（HRpQCT）对桡骨和胫骨的骨评估，以及骨转换的生物标志物。
BEACON 通过研究旨在优化 WL 老年人骨骼完整性的两种可扩展干预策略的独立和联合作用，解决了一个研究不足但很重要的临床研究问题。
NCT05764733。
