Risedronate for Bone Loss After Bariatric Surgery

This study is investigating whether a medication called risedronate can help reduce bone loss after sleeve gastrectomy (a type of weight-loss surgery). Risedronate is already approved to prevent and treat osteoporosis (a condition that makes bones weak) in older adults. Researchers want to see if it can also help people who have had sleeve gastrectomy. You may be able to join if you've had sleeve gastrectomy, are at least 30 years old, and weigh less than 450 lbs. The study will compare risedronate to a placebo (an inactive pill) to see if risedronate can improve bone mineral density in the hip over 6 and 12 months. The current status of this study is unclear.

Study design
This interventional study plans to enroll 200 participants. Participants will be randomly assigned to receive either risedronate or a placebo.
What's involved
Participation will involve up to 6 study visits and last about 1 year. You will complete two visits before starting the intervention.
Compensation
Not stated in the trial record.
Follow-up
Bone mineral density will be measured at baseline, 6 months, and 12 months after the intervention begins.

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NCT04922333

Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery

Recruiting
PHASE3Ages 30+InterventionalPrevention
Wake Forest University Health Sciences
~200 participants
Updated 2026-02-19 on ClinicalTrials.gov
What's tested:RisedronatePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Total Hip Areal Bone Mineral Density (aBMD)
Measured over baseline through Month 6
+1 more outcome measured
Bone Loss
1 sites across 1 states
North Carolina1
  • Kristen Beavers, PhD, MPH, RD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences
  • Jamy Ard, MD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.
  • Change in Total Hip Areal Bone Mineral Density (aBMD)baseline through Month 6

    Acquired through DXA scans.

  • Change in Total Hip Areal Bone Mineral Density (aBMD)baseline through Month 12

    Acquired through DXA scans.