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Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery

RecruitingPhase 3Ages 30 Years - anyAllWake Forest University Health Sciences
NCT04922333 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 r

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📋 Eligibility rules (as published)
Inclusion Criteria: * Subjects who have had sleeve gastrectomy * Willing to provide informed consent * Agree to all study procedures and assessments. Exclusion Criteria: * 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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What it tests

  • Risedronate
  • Placebo
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Where

1 site
Wake Forest School of Medicine
Winston-Salem, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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