Overview

Bisphosphonate Use to Mitigate Bone Loss

Status:
Not yet recruiting

Trial end date:
2025-09-01

Target enrollment:
0

Participant gender:
All

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).

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Wake Forest University Health Sciences

Treatments:

Risedronic Acid

Criteria

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.