Table 5. Secondary outcome comparisons between and within groups (PP population < 25th percentile)

Variable Observed value Changed from baseline
CG (n = 40) EG (n = 40) p** CG (n = 40) p* EG (n = 40) p* p**
HV (cm/year)
 visit 3 7.67 ± 6.05 14.21 ± 11.68 0.001 0.002 - - - - -
 visit 4 6.27 ± 5.27 6.46 ± 5.48 0.863 0.353 - - - - -
 visit 5 5.22 ± 4.98 5.80 ± 4.43 0.552 0.766 - - - - -
 visit 6 6.32 ± 4.47 9.10 ± 4.49 0.004 0.013 - - - - -
Height SDS
 visit 2 –1.39 ± 0.55 –1.35 ± 0.59 0.719
 visit 3 –1.34 ± 0.56 –1.17 ± 0.64 0.185 0.05 ± 0.15 0.016 0.18 ± 0.23 < 0.001 0.002 0.002
 visit 4 –1.32 ± 0.55 –1.15 ± 0.65 0.161 0.07 ± 0.13 0.001 0.20 ± 0.24 < 0.001 0.001 0.008
 visit 5 –1.33 ± 0.55 –1.15 ± 0.65 0.170 0.07 ± 0.13 0.001 0.20 ± 0.25 < 0.001 0.002 0.018
 visit 6 –1.31 ± 0.55 –1.08 ± 0.64 0.066 0.08 ± 0.14 <0.001 0.27 ± 0.26 < 0.001 < 0.001 0.001
BA (months)
 visit 2 81.15 ± 25.90 92.61 ± 25.51 0.034
 visit 6 89.72 ± 26.01 100.93 ± 24.84 0.036 8.57 ± 6.75 < 0.001 8.33 ± 10.07 < 0.001 0.889 0.551
GH (ng/mL)
 visit 2 2.22 ± 2.42 2.90 ± 3.96 0.323
 visit 6 1.83 ± 2.76 1.40 ± 1.58 0.358 –0.39 ± 3.53 0.453 –1.50 ± 3.57 0.007 0.135 0.263
IGF-1 (ng/mL)
 visit 2 187.69 ± 63.98 216.30 ± 107.92 0.125
 visit 6 168.19 ± 64.48 204.69 ± 95.50 0.034 –19.50 ± 31.76 <0.001 –11.62 ± 46.58 0.098 0.342 0.255
IGFBP-3 (ng/mL)
 visit 2 4525.11 ± 945.80 4607.61 ± 959.37 0.677
 visit 6 4185.11 ± 889.47 4584.57 ± 983.26 0.043 –340.00 ± 534.16 <0.001 –23.04 ± 723.45 0.830 0.018 0.006
Osteocalcin (ng/mL)
 visit 2 57.59 ± 13.64 65.45 ± 20.65 0.033
 visit 6 74.40 ± 22.59 82.72 ± 20.99 0.069 16.81 ± 16.97 <0.001 17.26 ± 22.28 < 0.001 0.912 0.827
DPD (nM/mM.cre)
 visit 2 18.81 ± 6.13 18.17 ± 5.46 0.597
 visit 6 14.68 ± 4.68 15.29 ± 8.22 0.662 –4.13 ± 6.99 <0.001 –2.88 ± 10.78 0.077 0.508 0.457
p-values were derived from paired t-test (comparing within each group).
p-values were compared between groups (The values are from left to right: 1st, independent t-test; 2nd, ANCOVA [covariate: sex]; 3rd, ANCOVA [covariate: weight]; 4th, ANCOVA [covariate: change of caloric intake]).
CG, control group; EG, experimental group; HV, height velocity; SDS, standard deviation scores; BA, bone age; GH, growth hormone; IGF-1, insulin-like growth factor 1; IGFBP-3, insulin-like growth factor-binding protein 3; DPD, deoxypyridinoline.