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JBMR Plus. 2020 Oct 02;4(10):e10407. doi: 10.1002/jbm4.10407. eCollection 2020 Oct.

Risedronate to Prevent Bone Loss After Sleeve Gastrectomy: Study Design and Feasibility Report of a Pilot Randomized Controlled Trial.

JBMR plus

Ashlyn A Swafford, Jamy D Ard, Daniel P Beavers, Peri C Gearren, Adolfo Z Fernandez, Sherri A Ford, Katelyn A Greene, Daniel E Kammire, Beverly A Nesbit, Kylie K Reed, Ashley A Weaver, Kristen M Beavers

Affiliations

  1. Deparment of Health and Exercise Science Wake Forest University Winston-Salem NC USA.
  2. Weight Management Center Wake Forest Baptist Medical Center Winston-Salem NC USA.
  3. Department of Biostatistics and Data Science Wake Forest School of Medicine Winston-Salem NC USA.
  4. Department of Biomedical Engineering Wake Forest School of Medicine Winston-Salem NC USA.

PMID: 33103032 PMCID: PMC7574708 DOI: 10.1002/jbm4.10407

Abstract

Mounting evidence implicates bariatric surgery as a cause of increased skeletal fragility and fracture risk. Bisphosphonate therapy reduces osteoporotic fracture risk and may be effective in minimizing bone loss associated with bariatric surgery. The main objective of this pilot randomized controlled trial (RCT; Clinical Trial No. NCT03411902) was to determine the feasibility of recruiting, treating, and following 24 older patients who had undergone sleeve gastrectomy in a 6 month RCT examining the efficacy of 150-mg once-monthly risedronate (versus placebo) in the prevention of surgical weight-loss-associated bone loss. Feasibility was defined as: (i) >30% recruitment yield, (ii) >80% retention, (iii) >80% pills taken, (iv) <20% adverse events (AEs), and (v) >80% participant satisfaction. Study recruitment occurred over 17 months. Seventy participants were referred, with 24 randomized (34% yield) to risedronate (

CLINICAL TRIAL REGISTRATION: http://clinicaltrials.gov/show/NCT03411902. Weight Loss With Risedronate for Bone Health. © 2020 The Authors.

© 2020 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

Keywords: ANTIRESORPTIVES; BONE QUANTITATIVE COMPUTED TOMOGRAPHY; CLINICAL TRIALS; DXA; FRACTURE PREVENTION

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