Background: We compared the clinical efficacy and safety of combined treatment with alendronate (ALN) plus eldecalcitol (ELD) with those of treatment with ALN supplemented with vitamin D and calcium.
Methods: Osteoporotic 219 patients were randomly assigned to a group prescribed ELD at 0.75 μg/day plus ALN at 35 mg/week (ALN + ELD group), or a group prescribed vitamin D3 at 400 IU/day, calcium at 610 mg/day, and ALN at 35 mg/week (ALN + VitD group) for 48 weeks. Primary endpoint was the inter-group differences in lumbar spine BMD (L-BMD) at patients last visit. Secondary endpoints included the differences in BMD at other sites and the bone turnover markers (BTMs) levels.
Results: L-BMD, total hip BMD and femoral neck (FN-BMD) increased from baseline by 7.30, 2.41 and 2.70% in the ALN + ELD group, and by 6.52, 2.27 and 1.18% in the ALN + VitD group, respectively. Inter-group differences of the L-BMD and total hip BMD values were not significant. The increase of the FN-BMD was larger in the ALN + ELD group than the ALN + VitD group. Reductions of the BTMs were greater in the ALN + ELD group than the ALN + VitD group. The increase in L-BMD strongly correlated with the baseline values of the BTMs in the ALN + VitD group, whereas, the L-BMD increased regardless of baseline BTM in the ALN + ELD group. The safety profile did not differ between the two groups.
Conclusion: Combination treatment of ALN plus ELD was more effective in reducing the BTMs and increasing the FN-BMD than ALN treatment with vitamin D3 and calcium.
*e-ADVANCED Study = Eldecalcitol; Alendronate plus vitamin D Vs. AleNdronate Combined with ElDecalcitol Study.
Disclosure: The authors declared no competing interests. AS has received consultant fee and honoraria from Astellas, Chugai and Taisho-Toyama. The study was funded by Taisho Pharmaceutical Co. Ltd.