Risedronate use may blunt appendicular lean mass loss secondary to sleeve gastrectomy: Results from a pilot randomized controlled trial.

Abstract

Despite robust weight loss and cardiometabolic benefit, lean mass loss following sleeve gastrectomy (SG) confers health risk. Bisphosphonates are a potential therapeutic agent for lean mass maintenance. Thus, our objective was to explore the effect of six months of risedronate (vs placebo) on change in dual energy x-ray absorptiometry (DXA) and computed tomography (CT) derived lean mass metrics in the year following SG. 24 SG patients were randomized to six months of 150 mg oral risedronate or placebo capsules (NCT03411902). Body composition was assessed at baseline and six months with optional 12-month follow-up using whole-body DXA and CT at the lumbar spine and mid-thigh. Group treatment effects and 95% CIs were generated from a mixed model using contrast statements at six and 12 months, adjusted for baseline values. Of 24 participants enrolled [55.7±6.7 years (mean±SD), 79% Caucasian, 83% women, body mass index (BMI) 44.7±6.3kg/m2], 21 returned for six-month testing, and 14 returned for 12-month testing. Six-month weight loss was -16.3 kg (-20.0, -12.5) and -20.9 kg (-23.7, -18.1) in the risedronate and placebo groups, respectively (p=.057). Primary analysis at six-months revealed a non-significant sparing of appendicular lean mass in the risedronate group compared to placebo [-1.2 kg (-2.3, -0.1) vs -2.1 kg (-3.0, -1.2)]; p=.20. By 12-months, the risedronate group displayed no change in appendicular lean mass from baseline [-0.5 kg (-1.5, 0.6)]; however, the placebo group experienced significantly augmented loss [-2.9 kg (-3.6, -2.1)]. Pilot data indicate risedronate treatment may mitigate appendicular lean mass loss following SG. Further study is warranted.