Item Details

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)

2022-05-28T08:30:14Z (available)

2020 (issued)

degree

Health and Exercise Science (discipline)

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