Weight Loss With Risedronate for Bone Health (WERISE)

Effect of Bisphosphonate Use on Surgical Weight Loss Associated Bone Loss in Older Adults With Morbid Obesity

This is a pilot project to determine the feasibility of recruiting, enrolling, treating, and following 24 older sleeve gastrectomy patients into a randomized controlled trial (RCT) examining the efficacy of bisphosphonate use versus placebo in the prevention of surgical weight loss associated loss of bone mass and quality.

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.

This pilot study is a RCT, involving 24 sleeve gastrectomy patients randomized to Risedronate or placebo capsules for 24 weeks

Both participant and research associate charged with administering medication or placebo capsules will be blinded.

Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.

Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.

Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Fat pounds portion of Total body composition

Duel-energy x-ray absorptiometry (DXA)-Acquired Measure--Lean pounds portion of Total body composition

Duel-energy X-ray Absorptiometry (DXA)-Acquired Measure for Ultradistal Radius (or UD Radius) Density

TBS of the lumbar spine measured by two dimensional (2D) variogram acquired through duel-energy x-ray absorptiometry (DXA). Trabecular bone score is a unitless index of bone microarchitecture. A high TBS value means that bone microarchitecture is dense and well connected, with little space between trabeculae. The following normal range for TBS values in postmenopausal women has been proposed: TBS >=1.350 is considered to be normal; TBS between 1.200 and 1.350 is considered to be consistent with partially degraded microarchitecture; and TBS <=1.200 defines degraded microarchitecture

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

Swafford AA, Ard JD, Beavers DP, Gearren PC, Fernandez AZ, Ford SA, Greene KA, Kammire DE, Nesbit BA, Reed KK, Weaver AA, Beavers KM. Risedronate to Prevent Bone Loss After Sleeve Gastrectomy: Study Design and Feasibility Report of a Pilot Randomized Controlled Trial. JBMR Plus. 2020 Oct 2;4(10):e10407. doi: 10.1002/jbm4.10407. eCollection 2020 Oct.