Status:
COMPLETED
Weight Loss With Risedronate for Bone Health
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Wake Forest University
Conditions:
Bariatric Surgery Candidate
Bone Loss
Eligibility:
All Genders
40-79 years
Phase:
PHASE4
Brief 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 effic...
Detailed Description
This pilot study is a RCT, involving 24 participants randomized to Risedronate or placebo capsules for 24 weeks. All subjects planning a sleeve gastrectomy (SG) procedure will be approached during the...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03411902
Start Date
June 15 2018
End Date
July 22 2020
Last Update
February 9 2021
Active Locations (1)
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1
Wake Forest University
Winston-Salem, North Carolina, United States, 27106