Home › Metabolic Bone Diseases › NCT04922333

Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery

Who can join

Ages 30 and older · All sexes

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.

About the study

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).

What is being tested

• Risedronate (drug)
• Placebo (drug)

Sponsor: Wake Forest University Health Sciences · Participants: 200 · Started: Mar 28, 2023

Contact the study team

• Kristen Beavers, PhD, MPH, RD · Phone: 336-758-5855

Official record on ClinicalTrials.gov — NCT04922333

Locations in the U.S.

Conditions

• Metabolic Bone Diseases

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.