Table 4.
Efficacy Comparison by treatment group at each assessment periods.
| Variable | Value | p-Value 1 | |
|---|---|---|---|
| Placebo (n = 18) | Treatment (n = 16) | ||
| Height (cm) | 1.03 cm/3 month | 1.43 cm/3 month | |
| Screening | 126.93 ± 7.05 | 121.43 ± 7.89 | 0.0394 2 |
| Visit 1 | 127.38 ± 7.10 | 121.60 ± 7.98 | 0.0326 2 |
| Visit 2 | 127.88 ± 7.03 | 122.25 ± 8.18 | 0.0386 2 |
| Visit 3 | 128.41 ± 7.06 | 123.03 ± 7.84 | 0.0430 2 |
| Change from baseline | 1.03 ± 0.51 | 1.43 ± 0.68 | 0.0639 2 |
| IGF-1 | 0.27 | 9.57 | |
| Screening | 69.85 ± 16.36 | 64.95 ± 20.85 | 0.3496 3 |
| Visit 3 | 70.12 ± 19.94 | 74.52 ± 19.38 | 0.3162 3 |
| Change from baseline | 0.26 ± 13.69 | 9.57 ± 12.69 | 0.0488 2 |
| Osteocalcin | |||
| Screening | 66.80 ± 27.59 | 75.96 ± 30.49 | 0.3003 3 |
| Visit 3 | 58.72 ± 27.56 | 89.44 ± 19.92 | 0.0058 3 |
| Change from baseline | −8.08 ± 18.33 | 13.48 ± 25.12 | 0.0070 2 |
1p-values were adjusted for observed value at baseline by using baseline value as covariate in analysis of covariance. Baseline value (screening or visit 1) was adjusted in ANCOVA analysis. 2p-values were derived from independent t-test. 3p-values were derived from Mann-Whitney’s U test. Shapiro-Wilk’s test was employed for test of normality assumption.