Risedronate use to attenuate bone loss following sleeve gastrectomy: Results from a pilot randomized controlled trial.

The purpose of this study was to explore the efficacy of 150 mg once monthly oral risedronate use in the prevention of sleeve gastrectomy (SG) associated bone loss. Twenty-four SG patients (56 ± 7 years, 83% female, 21% black) were randomized to risedronate or placebo for 6 months, with an optional 12-month assessment. Outcome measures included 6 (n = 21) and 12 (n = 14) month change in dual energy x-ray absorptiometry-acquired regional areal bone mineral density (aBMD). Six-month treatment effect estimates [mean (95% CI)] revealed significant between group aBMD differences at the femoral neck [risedronate: +0.013 g/cm(2) (-0.021, 0.046) vs. placebo: -0.041 g/cm(2) (-0.067, -0.015)] and lumbar spine [risedronate: +0.028 g/cm(2) (-0.006, 0.063) vs. placebo: -0.029 g/cm(2) (-0.054, -0.004)]; both p ≤ 0.02. When followed postoperatively to 12 months, differential aBMD treatment effects were observed at the total hip [risedronate: -0.035 g/cm(2) (-0.061, -0.009) vs. placebo: -0.072 g/cm(2) (-0.091, -0.052)] and lumbar spine [risedronate: +0.012 g/cm(2) (-0.038, 0.063) vs. placebo: -0.052 g/cm(2) (-0.087, -0.017)]; both p < 0.05. Preliminary treatment effect estimates signal 6 months of risedronate use may be efficacious in reducing aBMD loss at the axial skeleton post-SG, with benefit largely maintained throughout the 1-year postoperative period. Confirmatory data from an adequately powered trial are needed.