. 2024 Nov:146:107692.

doi: 10.1016/j.cct.2024.107692. Epub 2024 Sep 17.

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

Kristen M Beavers¹, Brianna R Wolle², Jamy D Ard³, Daniel P Beavers⁴, Olivia Biehl⁵, Peter H Brubaker², Andrew J Burghardt⁶, Christa T Calderone², Julio Carballido-Gamio⁷, Jason Fanning², Wendy M Kohrt⁸, Monica Love², Catherine M MacLean², Barbara J Nicklas⁹, Joshua Stapleton¹⁰, Christine M Swanson¹¹, Ashley A Weaver¹⁰, Marcelina Worden⁵, Sarah J Wherry⁸

Affiliations

¹ Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA. Electronic address: beaverkm@wfu.edu.
² Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA.
³ Department of Epidemiology and Prevention, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
⁴ Department of Statistical Sciences, Wake Forest University, Winston-Salem, NC, USA.
⁵ Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, USA.
⁶ Department of Radiology and Biomedical Imaging, University of California San Francisco, San Francisco, CA, USA.
⁷ Department of Radiology, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
⁸ Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, USA; Eastern Colorado Geriatric Research, Education, and Clinical Center (GRECC), Aurora, CO, USA.
⁹ Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
¹⁰ Department of Biomedical Engineering, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
¹¹ Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, University of Colorado Anschutz Medical Campus, USA; Eastern Colorado Geriatric Research, Education, and Clinical Center (GRECC), Aurora, CO, USA.

PMID: 39293778
PMCID: PMC11531379 (available on 2025-11-01)
DOI: 10.1016/j.cct.2024.107692

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

Kristen M Beavers et al. Contemp Clin Trials. 2024 Nov.

. 2024 Nov:146:107692.

doi: 10.1016/j.cct.2024.107692. Epub 2024 Sep 17.

Authors

Affiliations

¹ Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA. Electronic address: beaverkm@wfu.edu.
² Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA.
³ Department of Epidemiology and Prevention, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
⁴ Department of Statistical Sciences, Wake Forest University, Winston-Salem, NC, USA.
⁵ Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, USA.
⁶ Department of Radiology and Biomedical Imaging, University of California San Francisco, San Francisco, CA, USA.
⁷ Department of Radiology, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
⁸ Division of Geriatric Medicine, University of Colorado Anschutz Medical Campus, USA; Eastern Colorado Geriatric Research, Education, and Clinical Center (GRECC), Aurora, CO, USA.
⁹ Department of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
¹⁰ Department of Biomedical Engineering, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
¹¹ Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, University of Colorado Anschutz Medical Campus, USA; Eastern Colorado Geriatric Research, Education, and Clinical Center (GRECC), Aurora, CO, USA.

PMID: 39293778
PMCID: PMC11531379 (available on 2025-11-01)
DOI: 10.1016/j.cct.2024.107692

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.

Keywords: Aging; Bone; Exercise; Pharmacotherapy; Weight loss.

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Conflict of interest statement

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.

References

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

References

Publication types

MeSH terms

Substances

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical