Adverse events (AEs) occurring after teriparatide injection were collected. Data and statistical analysis Teriparatide plasma concentration was expressed as mean ± SD. PK analyses were performed on women who received active drug treatment by calculating the time course of plasma drug concentration and several PK parameters (Cmax, AUClast, AUCinf, Tmax, and T1/2). The calcium metabolic markers and bone turnover markers were expressed

as the mean absolute CHIR-99021 mw values or mean percent changes from baseline. The corresponding mean placebo values were subtracted from the percent changes in order to eliminate the diurnal and daily variations of the markers. AEs (e.g., symptoms and abnormal

changes in laboratory values) were summarized after coding and classified according to system organ class and see more preferred term using MedDRA/J (version 9.0). Statistical analysis using Dunnett’s test was performed find more to examine the differences between the placebo and the two teriparatide groups. Ethical considerations The protocol of the present study was approved by the Ethical Committee of the Medical Corporation Shinanokai Shinanozaka Clinic. Written informed consent was obtained from all participants prior to their participation in the study. Results Subjects Thirty subjects (ten per group) were randomized into the three treatment groups (placebo, 28.2 μg or 56.5 μg teriparatide). There were no dropouts during the study period. The subject characteristics of the three groups were well balanced at baseline, and there were no significant differences between the groups (Table 1). The serum level of 25(OH)D

in the 28.2 μg dose group seemed to be lower than that in the other groups. However, none of the groups had a level less than 10 ng/mL, suggesting that vitamin D deficiency at baseline was not included. Table 1 Characteristics of subjects   Placebo group Digestive enzyme Teriparatide group (28.2 μg) Teriparatide group (56.5 μg) (n = 10) (n = 10) (n = 10) Age (years) 70.5 ± 4.2 72.7 ± 4.7 69.9 ± 3.9 Height (cm) 152.26 ± 5.36 151.34 ± 5.11 152.14 ± 4.43 Body weight (kg) 50.85 ± 7.68 57.25 ± 7.44 52.82 ± 7.19 BMI (kg/m2) 21.93 ± 3.03 25.08 ± 3.76 22.94 ± 3.88 Corrected serum Ca (mg/dL) 9.15 ± 0.28 9.12 ± 0.14 9.11 ± 0.19 Serum P (mg/dL) 3.97 ± 0.24 3.97 ± 0.28 3.97 ± 0.38 Serum intact PTH (pg/mL) 35.5 ± 9.6 35.4 ± 7.4 42.0 ± 7.1 Serum 25(OH)D (ng/mL) 21.48 ± 5.14 17.93 ± 8.34 21.04 ± 6.70 Serum 1,25(OH)2D (pg/mL) 58.6 ± 16.5 54.8 ± 16.7 57.8 ± 13.3 Serum osteocalcin (ng/mL) 10.00 ± 2.20 9.10 ± 2.28 9.43 ± 3.52 Serum PINP (ng/mL) 61.24 ± 17.53 55.34 ± 13.93 62.80 ± 26.23 Serum NTX (nM BCE/L) 14.44 ± 4.25 14.30 ± 3.45 14.22 ± 2.67 Urinary CTX (μg/mmol) 422.70 ± 176.79 415.80 ± 137.91 498.20 ± 164.