001) and 18 percentage points at 36 months (P < 0.001) ( Fig. 3C). Urinary NTX was also significantly lower with eldecalcitol than with alfacalcidol by 29 percentage points Galunisertib ic50 at 12 months (P < 0.001) and by 23 percentage points at 36 months (P < 0.001) ( Fig. 3D). Serum 25(OH)D levels were elevated from baseline to 83.0 (SE 1.0) and 86.2 (1.0) nmol/L in eldecalcitol and alfacalcidol groups, respectively, at 6 months and remained at similar

levels throughout the study (Fig. 4A). As a result, serum 25(OH)D levels were over 50 nmol/L in more than 92% of the patients during the study period. Serum 1,25(OH)2D was suppressed sharply to 65.7 (SE 1.5) pmol/L in eldecalcitol group, whereas it was modestly elevated to 138 (1.6) in alfacalcidol group at 6 months, and remained almost stable during the study in both groups (Fig. 4B). Serum intact PTH levels were suppressed at 6 months in both groups, but the suppression was less in eldecalcitol group than in alfacalcidol group (Fig. 4C), as reported previously [7] and [12]. No significant difference was observed between the eldecalcitol and alfacalcidol groups in the incidence of total non-vertebral fractures at 36 months (8.0 and 9.5%, respectively; hazard ratio, 0.85; 95% CI, 0.55–1.31). Analysis of the two pre-defined subgroups revealed that the incidence of non-vertebral fractures

tended to be PF-01367338 mouse lower at the major three sites (2.5 and 4.9%, respectively; hazard ratio, 0.51; 95% CI, 0.25–1.03). Post-hoc analysis of the fracture incidence in each of the three sites (humerus, wrist and hip) revealed that the incidence of only wrist fracture was significantly lower in the eldecalcitol group than in the alfacalcidol group at 36 months (1.1 and 3.6%, respectively; hazard ratio, 0.29; 95% CI, 0.11–0.77; P = 0.009) ( Fig. 5). No significant difference between the two groups was observed in the fracture incidence of any other non-vertebral Thymidylate synthase sites. Adverse events with more than 5% incidence in either of the two groups

are listed in Table 2. Urinary Ca excretion increased in both the eldecalcitol and alfacalcidol groups; mean postprandial urinary Ca levels at 36 months were 0.242 and 0.209 mg/dL GF (0.061 and 0.052 mmol/L GF), respectively. The increase in urinary Ca was not associated with a decrease in estimated glomerular filtration rate (eGFR) throughout the study period (69.0 ± 13.6 and 68.4 ± 14.5 at baseline, and 65.8 ± 14.4 and 66.7 ± 14.3 at 36 months with eldecalcitol and alfacalcidol, respectively; means ± SD). Increase in serum Ca over 10.4 mg/dL was observed at least once in the study in 111 and 71 patients, in eldecalcitol and alfacalcidol groups, respectively. Patients with hypercalcemia over 11.5 mg/dL (2.875 mmol/L) at least once during the study numbered 2 and 0 in the eldecalcitol and alfacalcidol groups, respectively.