Study of Risedronate to Prevent Bone and Muscle Loss After Sleeve Gastrectomy Surgery

What this Trial Is About

Researchers are evaluating whether the medication risedronate, a bisphosphonate approved for osteoporosis, can reduce bone and muscle loss after vertical sleeve gastrectomy a type of bariatric surgery. This study focuses on middle-aged and older adults who have undergone this surgery to determine if risedronate helps preserve bone density and muscle function compared to a placebo. The trial aims to understand changes in bone and muscle using advanced imaging and muscle function tests, while also exploring related biological markers. Participants will be randomly assigned to receive either six monthly doses of 150 mg oral risedronate or a placebo pill over six months. The study has a triple-blind design, meaning neither participants nor staff know who receives the medication or placebo. Before starting, participants complete two screening visits. After the intervention, there are follow-up visits at 6 and 12 months to assess long-term effects. Monthly contacts are made to remind participants to take their pills and check for any side effects. Participants will attend up to six study visits during the first year, including baseline, 6-month, and 12-month assessments. These visits include various bone density scans DXA, QCT, HR-pQCT at several skeletal sites and muscle function tests such as a fast 400-meter walk, stair climb, and knee strength. Blood tests will measure biomarkers related to bone turnover, muscle interaction, and gut hormones. The main outcome is the change in total hip bone density over 12 months, alongside secondary measures of bone structure and muscle health.

Bisphosphonate Use to Mitigate Bone Loss Secondary to Bariatric Surgery