Two-Year Outcomes on Bone Density and Fracture Incidence in Patients with T2DM Randomized to Bariatric Surgery Versus Intensive Medical Therapy

Objective: To determine the 2-year outcomes of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) vs. intensive medical therapy (IMT) on lean body mass, total bone mass, and bone mineral density (BMD) measures from the STAMPEDE trial. Methods: 54 subjects (BMI: 36 +/- 1 kg/m(2), age: 4864 years) with type 2 diabetes (T2DM) (HbA(1c): 9.7 +/- 2%) were randomized to IMT, RYGB, or SG and underwent DXA at baseline and at 1 and 2 years. Results: At 2 years, the reduction in BMI was similar after RYGB and SG and was greater than IMT (P < 0.001). Lean mass was reduced by similar to 10%, total bone mineral content reduced by similar to 8%, and hip BMD reduced by similar to 9% in both surgical groups and was significantly greater than IMT despite increases in vitamin D intake in all groups. The change in hip BMD correlated with weight loss (r = 0.84, P < 0.0001) and changes in lean mass (r = 0.74, P < 0.0001) and leptin (r = 0.53, P < 0.0001). Peripheral fractures were self-reported in RYGB (4/18 patients), SG (2/19 patients), and IMT (4/16 patients). Conclusions: Surgically induced weight loss is associated with modest reductions in lean mass, bone mineral content, and BMD, despite calcium and vitamin D supplementation in patients with T2DM. Awareness for bone loss is indicated for patients undergoing bariatric procedures.