Summary statistics using FAS were selleck also calculated for mean percent change from baseline in (L2–L4) BMD at 6 and 12 months. Secondary endpoints were analyzed using FAS. Mean percent change from baseline was calculated for biochemical markers

of bone metabolism at 1, 3, 6, 9, 12 months, and at the end of the study (M12, LOCF). Vertebral fractures were also examined at 12 months and at the end of the study (M12, LOCF) by calculating the frequency, as well as the difference between the treatment groups and the 95% confidence intervals (CI). Subgroup analysis on the primary endpoint was performed using the baseline values of the biochemical markers. A total of 1251 individuals provided written informed consent and, of these, 852 subjects (429 subjects in the 2.5 mg once-daily group and 423 subjects in the 75 mg once-monthly group) were enrolled into the study and randomized (Fig. 1). A subject who had registered twice was excluded from all analyses, and the FAS comprised 850 subjects (428 subjects in the 2.5 mg once-daily group and 422 subjects in the 75 mg once-monthly group). The PPS group included 711 subjects (368 subjects in the 2.5 mg once-daily group, and 343 subjects in the 75 mg once-monthly group). Study discontinuation or withdrawal occurred in 48 and 58 subjects, respectively, in the 2.5 mg once-daily and 75 mg once-monthly groups. Pretreatment events, Caspase inhibitor which were defined as any untoward medical occurrence in a subject who had signed

informed consent to participate in the current study but prior to administration of any study medication, and adverse events were the most common reasons for discontinuation or withdrawal in both groups through the treatment period. A summary of baseline demographics

and characteristics of randomized subjects is presented in Table 1. With the exception of CTX/CRN levels, which were slightly higher in the 2.5 mg once-daily group compared with the 75 mg once-monthly group, all key baseline demographics and primary disease characteristics were similar in the two treatment groups. Patient characteristics at cAMP baseline in the PPS were similar to those of the randomized set. Mean percent change (SD) from baseline in (L2–L4) BMD at the end of the study (M12, LOCF) in the FAS was 5.69 (4.00)% in the 2.5 mg once-daily group and 5.98 (4.54)% in the 75 mg once-monthly group. In the non-inferiority t-test, the 75 mg once-monthly group proved to be non-inferior to the 2.5 mg once-daily group (p < 0.0001). The difference between treatment groups was 0.28% (95% CI, − 0.31% to 0.88%). Mean percent change from baseline in (L2–L4) BMD at the end of the study (M12, LOCF) in the PPS was similar to that in the FAS. Mean percent change (SD) from baseline in (L2–L4) BMD in the FAS at 6 months in the 2.5 mg once-daily and 75 mg once-monthly treatment groups was 5.01 (3.62)% and 4.67 (4.16)%, respectively, and at 12 months it was 5.81 (4.02)% and 6.11 (4.50)%, respectively (Fig. 2).