Abstract:
Vitamin D insufficiency is common in patients with osteoporosis. We conducted a randomized trial comparing alendronate 70 mg combined with vitamin D3 5,600 IU in a single tablet (ALN-D5600, n = 257) with standard care chosen by the patients' personal physicians (n = 258) in patients with postmenopausal osteoporosis (BMD T score ≤2.5 or ≤1.5 and a prior fragility fracture) who had vitamin D insufficiency (serum 25[OH]D values 8-20 ng-ml) and who were at risk of falls. Virtually all patients randomized to standard care received bisphosphonate therapy, and in approximately 70percent of cases this was combined with vitamin D supplements. However, only 24percent took ≥800 IU-day of supplemental vitamin D. At 6 months the proportion of patients with vitamin D insufficiency was 8.6percent in the ALN-D5600 group compared with 31.0percent in the standard care group (P andlt; 0.001). Those in the ALN-D5600 group also had a greater reduction in urinary NTX-creatinine ratio (-57percent vs. -46percent, P andlt; 0.001) and bone-specific alkaline phosphatase (-47percent vs. -40percent, P andlt; 0.001). In the ALN-5600 group, by 12 months the increase in BMD was greater at the lumbar spine (4.9percent vs. 3.9percent, P = 0.047) and the total hip (2.2percent vs. 1.4percent, P = 0.035), significantly fewer patients were vitamin D-insufficient (11.3percent vs. 36.9percent, P andlt; 0.001), and bone turnover marker (BTM) results were similar to those at 6 months. There was no difference between groups in those who experienced falls or fractures, and adverse events were similar. Based on the finding that ALN-D5600 was more effective than standard care at correcting vitamin D insufficiency, increasing BMD, and reducing BTMs in this patient group, greater attention needs to be directed toward optimizing the treatment of osteoporosis and correcting vitamin D deficiency in postmenopausal women. © 2011 Springer Science+Business Media, LLC.