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Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery
Sponsor: Wake Forest University Health Sciences
Summary
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).
Key Details
Gender
All
Age Range
30 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2023-03-28
Completion Date
2028-04-30
Last Updated
2026-02-19
Healthy Volunteers
No
Conditions
Interventions
Risedronate
150mg over-encapsulated risedronate
Placebo
Capsules containing placebo tablets
Locations (1)
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States