Using risedronate to prevent bone loss after bariatric surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to determine if the medication risedronate can effectively reduce bone and muscle loss in patients who have undergone bariatric surgery, specifically vertical sleeve gastrectomy. Participants will be randomized to receive either risedronate or a placebo for six months, with assessments of musculoskeletal outcomes at baseline, six months, and twelve months. The study will utilize advanced imaging techniques and biomarkers to evaluate changes in bone density, muscle function, and other relevant health indicators. The trial will involve up to six visits over the course of one year, including monthly follow-ups to monitor participant health and adherence to the medication regimen.

Why it matters

Who can join: the full rules

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.

Where it's running

• Wake Forest School of Medicine
  Winston-Salem, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Kristen Beavers, PhD, MPH, RD — Wake Forest University Health Sciences
• Study coordinator: Kristen Beavers, PhD, MPH, RD
• Email: beaverkm@wfu.edu
• Phone: 336-758-5855

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.