Weight Loss With Risedronate for Bone Health

Completed · Phase 4 · Has a placebo group

Conditions studied: Bariatric Surgery Candidate, Bone Loss, Weight Loss

In brief

This is a pilot project to determine the feasibility of recruiting, enrolling, treating, and following 24 older sleeve gastrectomy patients into a randomized controlled trial (RCT) examining the efficacy of bisphosphonate use versus placebo in the prevention of surgical weight loss associated loss of bone mass and quality.

Key facts

Study ID

NCT03411902

Run by

Wake Forest University Health Sciences

People needed

24

Starts

2018-06-15

Expected to finish

2020-07-22

Last updated by the study team

2021-02-09

Who can join

Age: 40 and older, up to 79. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects planning a sleeve gastrectomy procedure
• 40-79 yrs of age
• Willingness to provide informed consent
• Agreement to all study procedures and assessments

You may not qualify if…

• Age <40 years
• Baseline weight >450 pounds
• Chronic anti-reflux treatment
• History of medical disorders known to affect bone metabolism
• Use of bone-active medications
• Known allergy to Risedronate

Where it is running

• Wake Forest University — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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