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The Bone, Exercise, Alendronate, and Caloric Restriction (BEACON) trial design and methods.
Beavers, Kristen M; Wolle, Brianna R; Ard, Jamy D; Beavers, Daniel P; Biehl, Olivia; Brubaker, Peter H; Burghardt, Andrew J; Calderone, Christa T; Carballido-Gamio, Julio; Fanning, Jason; Kohrt, Wendy M; Love, Monica; MacLean, Catherine M; Nicklas, Barbara J; Stapleton, Joshua; Swanson, Christine M; Weaver, Ashley A; Worden, Marcelina; Wherry, Sarah J.
Afiliación
  • Beavers KM; Departments of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, United States of America. Electronic address: beaverkm@wfu.edu.
  • Wolle BR; Departments of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, United States of America.
  • Ard JD; Departments of Epidemiology and Prevention, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
  • Beavers DP; Departments of Statistical Sciences, Wake Forest University, Winston-Salem, NC, United States of America.
  • Biehl O; Divisions of Geriatric Medicine, University of Colorado Anschutz Medical Campus, USA.
  • Brubaker PH; Departments of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, United States of America.
  • Burghardt AJ; Department of Radiology and Biomedical Imaging, University of California San Francisco, San Francisco, CA, USA.
  • Calderone CT; Departments of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, United States of America.
  • Carballido-Gamio J; Department of Radiology, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
  • Fanning J; Departments of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, United States of America.
  • Kohrt WM; Divisions of Geriatric Medicine, University of Colorado Anschutz Medical Campus, USA; Eastern Colorado Geriatric Research, Education, and Clinical Center (GRECC), Aurora, CO, USA.
  • Love M; Departments of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, United States of America.
  • MacLean CM; Departments of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, United States of America.
  • Nicklas BJ; Departments of Internal Medicine, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
  • Stapleton J; Departments of Biomedical Engineering, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
  • Swanson CM; Divisions 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.
  • Weaver AA; Departments of Biomedical Engineering, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
  • Worden M; Divisions of Geriatric Medicine, University of Colorado Anschutz Medical Campus, USA.
  • Wherry SJ; Divisions of Geriatric Medicine, University of Colorado Anschutz Medical Campus, USA; Eastern Colorado Geriatric Research, Education, and Clinical Center (GRECC), Aurora, CO, USA.
Contemp Clin Trials ; : 107692, 2024 Sep 16.
Article en En | MEDLINE | ID: mdl-39293778
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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Contemp Clin Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Contemp Clin Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos