RecruitingPhase 3NCT04922333

Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery


Sponsor

Wake Forest University Health Sciences

Enrollment

200 participants

Start Date

Mar 28, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether a type of medication called bisphosphonates (often used to treat osteoporosis) can prevent bone loss that sometimes happens after sleeve gastrectomy (a common weight-loss surgery). People who have this surgery can sometimes lose bone density over time, and this study aims to find out if bisphosphonates can help protect bone health. You may be eligible if: - You have had sleeve gastrectomy (a type of bariatric/weight-loss surgery) - You are 30 years or older - You are willing to follow all study procedures You may NOT be eligible if: - You weigh more than 450 lbs - You regularly use growth hormones, oral steroids, or prescription osteoporosis medications - You have a known allergy to bisphosphonates - You have unstable acid reflux requiring frequent extra medication - You are currently in another research study - You cannot arrange your own transportation to study visits - You need help positioning yourself on the scanner Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGRisedronate

150mg over-encapsulated risedronate

DRUGPlacebo

Capsules containing placebo tablets


Locations(1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04922333


Related Trials