Overview

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