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

Inclusion Criteria3

  • Subjects who have had sleeve gastrectomy
  • Willing to provide informed consent
  • Agree to all study procedures and assessments.

Exclusion Criteria7

  • 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.

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Interventions

DRUGRisedronate

150mg over-encapsulated risedronate

DRUGPlacebo

Capsules containing placebo tablets


Locations(1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

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NCT04922333


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