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BISPHOSPHONATES AS A NOVEL THERAPEUTIC TO PRESERVE BONE DENSITY DURING SURGICAL WEIGHT LOSS: A PILOT TRIAL

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abstract
The purpose of this study is to determine the feasibility of a randomized controlled trial (RCT) examining bisphosphonate use (versus placebo) in 24 SG patients (≥40 years old) in the prevention of bariatric surgery associated bone loss. Feasibility metrics include recruitment, retention, adherence, safety, and satisfaction. Self-reported demographic characteristics and dual energy X-ray absorptiometry (DXA) acquired T-scores and 10-year major osteoporotic fracture (MOF) and hip fracture risk were also collected at baseline. Study recruitment occurred over 17 months (3/5/18-8/31/19). 70 patients met initial eligibility criteria and were referred by the clinic; of those, 32 were screened by telephone (n=8 excluded after screening), and 24 were randomized to bisphosphonate or placebo (recruitment yield: 34%; n=13 placebo; n=11 bisphosphonate). Among active participants, 92% of pills (133 out of 144 total) were taken (n=22>80% compliant with medication protocol). Four AEs (134 contacts; 3% AE rate) were reported; none serious and no withdraws occurred due to medication intolerance. All participants reported being highly satisfied with participation in the study. Use of bisphosphonates as a novel therapeutic to preserve bone density among SG patients appears feasible and well tolerated. Knowledge gained from this study will be used to inform and appropriately power a subsequent trial.
subject
Bisphosphonates
Bone mineral density
Feasibility
Pilot trial
Randomized controlled trial
Sleeve gastrectomy
contributor
Swafford, Ashlyn (author)
Beavers, Kristen M (committee chair)
Katula, Jeffrey (committee member)
Ard, Jamy D (committee member)
date
2020-05-29T08:36:04Z (accessioned)
2020 (issued)
degree
Health and Exercise Science (discipline)
2022-05-28 (liftdate)
embargo
2022-05-28 (terms)
identifier
http://hdl.handle.net/10339/96835 (uri)
language
en (iso)
publisher
Wake Forest University
title
BISPHOSPHONATES AS A NOVEL THERAPEUTIC TO PRESERVE BONE DENSITY DURING SURGICAL WEIGHT LOSS: A PILOT TRIAL
type
Thesis

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