Thus, the reason Bcl-2 inhibitor for the dissipation of the suppressive effect of both eldecalcitol and alfacalcidol on intact PTH and BSAP levels after 6 months of treatment remains unclear. The present study included 24 male patients; 9 of them were in eldecalcitol group and 15 of them were in alfacalcidol group. Incident vertebral fracture occurred in one out of 9 males and 2 out of 15 males in eldecalcitol and alfacalcidol groups, respectively. Mean changes in lumbar BMD were 10.9 and

− 0.24 percentage points after 36 months of treatment with eldecalcitol and alfacalcidol, respectively. Mean changes in total hip BMD were 1.8 and − 0.61 percentage points after 36 months of treatment with eldecalcitol and alfacalcidol, respectively. From these results, the effect of eldecalcitol may be superior among males as well. However, the number of subjects was too small to draw Dabrafenib concentration any conclusions, and larger studies are

needed to clarify this issue. There was no significant difference in the incidence of any adverse events, and the number of serious adverse events was smaller in the eldecalcitol-treated group. Although the incidence of urinary Ca increase over 0.4 mg/dL GF was higher in the eldecalcitol group, the incidence of urolithiasis was the same and no significant difference in eGFR was observed between the two groups. In addition, the incidence of hypercalcemia of greater than 11.5 mg/dL was low in both groups (2 and 0 in the eldecalcitol

and alfacalcidol groups, respectively). These results many demonstrate that eldecalcitol is safe for at least 3 years. The present study has limitations. First, the present study lacked a placebo group. Second, as a limitation relating to the size of the study as an active comparator study, the statistical significance of the primary endpoint was predefined as a two-sided alpha of 0.10 with 90% confidence interval. Finally, although there was no statistical difference in the incidence of hypercalcemia over 11.5 mg/dL or urolithiasis between the eldecalcitol and alfacalcidol groups, the incidence of increase in serum and urinary Ca was significantly higher in the eldecalcitol group. Therefore, the long-term safety of eldecalcitol needs to be studied. In conclusion, in vitamin D-sufficient patients with osteoporosis, daily treatment with 0.75 μg eldecalcitol for 3 years is associated with a lower risk of vertebral and wrist fractures, greater improvements in lumbar spine BMD, and greater decreases in bone turnover than daily treatment with 1.0 μg alfacalcidol. The long-term efficacy and safety remains to be studied. The present study was sponsored by Chugai Pharmaceutical Co., Ltd. The sponsor of the study participated in study design, data collection, data analyses, data interpretation, and writing of the report. The sponsor supplied the study medication, and had responsibility for data collection and quality control.