1. The Bone, Exercise, Alendronate, and Caloric Restriction (BEACON) trial design and methods.
- Author
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Beavers KM, Wolle BR, Ard JD, Beavers DP, Biehl O, Brubaker PH, Burghardt AJ, Calderone CT, Carballido-Gamio J, Fanning J, Kohrt WM, Love M, MacLean CM, Nicklas BJ, Stapleton J, Swanson CM, Weaver AA, Worden M, and Wherry SJ
- Subjects
- Humans, Aged, Female, Male, Middle Aged, Weight Loss, Obesity therapy, Absorptiometry, Photon methods, Osteoporosis prevention & control, Research Design, Alendronate therapeutic use, Alendronate administration & dosage, Caloric Restriction methods, Bone Density drug effects, Bone Density Conservation Agents therapeutic use, Bone Density Conservation Agents administration & dosage, Resistance Training methods
- 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., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)- Published
- 2024
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