Weight Loss With Risedronate for Bone Health

This pilot study is a RCT, involving 24 participants randomized to Risedronate or placebo capsules for 24 weeks. All subjects planning a sleeve gastrectomy (SG) procedure will be approached during their pre-surgical evaluation for possible participation in the study. Eligible participants will be referred onto the study coordinator to read/sign an IRB-approved informed consent prior to enrollment.

Two in-person baseline assessment visits [baseline visit 1 (BV1), baseline visit 2 (BV2)] occurring 1-6 weeks prior to surgery, and two in-person follow up assessment visits [follow up visit 1 (FV1) and follow up visit 2 (FV2)] occurring ±2 weeks from their 23-week post-surgery date will be conducted, as well as monthly medication compliance reminders and adverse event reporting via phone. Optional additional exploratory assessments include CT-derive bone health and blood-based biomarkers, as well as 12-month DXA, CT, and blood assessments. The Wake Forest WMC, under the direction of Drs. Ard and Fernandez, will serve as a source of recruitment for potential study participants.

Inclusion criteria

• Subjects planning a sleeve gastrectomy procedure
• 40-79 yrs of age
• Willingness to provide informed consent
• Agreement to all study procedures and assessments

Exclusion criteria

• Age <40 years
• Baseline weight >450 pounds
• Chronic anti-reflux treatment
• History of medical disorders known to affect bone metabolism
• Use of bone-active medications
• Known allergy to Risedronate