Actively Recruiting
Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery
Led by Wake Forest University Health Sciences · Updated on 2026-02-19
200
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this research study is to see whether receiving a bisphosphonate medication called risedronate can reduce bone and muscle loss following bariatric surgery. Participation will involve up to 6 study visits and last about 1 year. Risedronate is a medication that prevents bone breakdown and has been approved by the US Food and Drug Administration (FDA) for the prevention and treatment of osteoporosis in older men and women. However, risedronate has not been approved for the prevention of bone and muscle loss following vertical sleeve gastrectomy. Participation in this study will involve completing two visits before beginning the intervention. Participants who qualify will be scheduled to begin the intervention program which will involve taking 6 monthly doses of a risedronate or placebo pill. Participants will then receive monthly contacts by study staff during this time to remind participants to take the intervention pill and ask about any adverse events. After the completion of intervention period, participants will complete up to 4 follow up study visits at 6 months (2 visits) and at 12 months (2 visits).
CONDITIONS
Official Title
Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects who have had sleeve gastrectomy
- Willing to provide informed consent
- Agree to all study procedures and assessments.
You will not qualify if you...
- Weight greater than 450 lbs
- Regular use of growth hormones, oral steroids, or prescription osteoporosis medications
- Known allergies to bisphosphonates
- Unstable gastric reflux requiring two or more additional doses per month of anti-reflux medication
- Current participation in other research study
- Unable to provide own transportation to study visits
- Unable to position on scanner independently
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
K
Kristen Beavers, PhD, MPH, RD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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