Weight Loss With Risedronate for Bone Health

• Status: Completed
• Trial end date: 2020-07-22
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborator: Wake Forest University
• Treatments: Etidronic Acid; Risedronate Sodium; Risedronic Acid

Criteria

Inclusion Criteria

• Subjects planning a sleeve gastrectomy procedure

• 40-79 yrs of age

• Willingness to provide informed consent

• Agreement to all study procedures and assessments

Exclusion Criteria

• 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