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RECRUITING
NCT04922333
PHASE3

Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

30 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2023-03-28

Completion Date

2028-04-30

Last Updated

2026-02-19

Healthy Volunteers

No

Conditions

Interventions

DRUG

Risedronate

150mg over-encapsulated risedronate

DRUG

Placebo

Capsules containing placebo tablets

Locations (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States