Table 2.
Comparison Between and Within Each Group (ITT Population)
| Variable | Observed value |
Change from baseline |
Effect size | ||
|---|---|---|---|---|---|
| Control (n = 50) | Experimental (n = 50) | Control (n = 50) | Experimental (n = 50) | ||
| Height (cm) | |||||
| visit 2 | 124.14 ± 9.26 | 126.17 ± 10.61 | |||
| visit 3 | 125.09 ± 9.27 | 127.68 ± 11.02 | 0.95 ± 0.76 | 1.51 ± 1.37* | 0.502 |
| visit 4 | 125.80 ± 9.32 | 128.36 ± 11.01 | 1.66 ± 0.79 | 2.19 ± 1.49* | 0.445 |
| visit 5 | 126.37 ± 9.22 | 128.98 ± 11.17 | 2.23 ± 0.76 | 2.81 ± 1.71* | 0.440 |
| visit 6 | 127.06 ± 9.39 | 129.95 ± 11.22 | 2.91 ± 0.84 | 3.78 ± 1.88** | 0.593 |
| HV (cm/year) | |||||
| visit 3 | 8.25 ± 6.60 | 14.21 ± 11.68** | – | – | 0.628 |
| visit 4 | 6.33 ± 5.44 | 6.46 ± 5.48 | – | – | 0.025 |
| visit 5 | 5.34 ± 5.20 | 5.80 ± 4.43 | – | – | 0.096 |
| visit 6 | 6.38 ± 4.72 | 9.10 ± 4.49** | – | – | 0.591 |
| Height SDS | |||||
| visit 2 | −1.39 ± 0.54 | −1.34 ± 0.57 | |||
| visit 3 | −1.33 ± 0.56 | −1.18 ± 0.62 | 0.06 ± 0.15 | 0.16 ± 0.22** | 0.535 |
| visit 4 | −1.31 ± 0.56 | −1.15 ± 0.63 | 0.08 ± 0.15 | 0.19 ± 0.24** | 0.553 |
| visit 5 | −1.31 ± 0.56 | −1.16 ± 0.63 | 0.08 ± 0.14 | 0.18 ± 0.25** | 0.524 |
| visit 6 | −1.30 ± 0.56 | −1.09 ± 0.62 | 0.09 ± 0.15 | 0.25 ± 0.26** | 0.751 |
| Bone ag (mo) | |||||
| visit 2 | 82.26 ± 26.07 | 92.68 ± 24.92* | |||
| visit 6 | 90.32 ± 25.89 | 100.34 ± 24.38* | 8.06 ± 6.86 | 7.66 ± 9.92 | −0.047 |
| GH (ng/mL) | |||||
| visit 2 | 2.26 ± 2.48 | 2.87 ± 3.84 | |||
| visit 6 | 1.89 ± 2.79 | 1.49 ± 1.64 | −0.37 ± 3.42 | −1.38 ± 3.44 | −0.295 |
| IGF-1 (ng/mL) | |||||
| visit 2 | 193.27 ± 69.13 | 214.41 ± 104.02 | |||
| visit 6 | 174.93 ± 71.20 | 203.72 ± 92.03 | −18.33 ± 31.12 | −10.69 ± 44.75 | 0.198 |
| IGFBP-3 (ng/mL) | |||||
| visit 2 | 4580.8 ± 958.79 | 4650.6 ± 948.29 | |||
| visit 6 | 4261.2 ± 930.17 | 4629.4 ± 971.48 | −319.60 ± 523.93 | −21.20 ± 693.32* | 0.486 |
| Osteocalcin (ng/mL) | |||||
| visit 2 | 58.27 ± 14.71 | 64.41 ± 20.26 | |||
| visit 6 | 74.07 ± 22.70 | 80.29 ± 21.90 | 15.80 ± 16.93 | 15.88 ± 21.87 | 0.004 |
| DPD (nM/mM.cre) | |||||
| visit 2 | 18.95 ± 6.57 | 18.11 ± 5.38 | |||
| visit 6 | 15.07 ± 5.54 | 15.46 ± 8.00 | −3.88 ± 6.85 | −2.65 ± 10.36 | 0.140 |
The data is expressed as the mean ± SD for pre and post outcomes and comparison between two groups. *, p < 0.05; **, p < 0.001 comparison between groups.
DPD, Urine Deoxypyridinoline; SD, standard deviation, GH, growth hormone; HV, height velocity; IGF-1, insulin-like growth factor 1; IGFBP-3, insulin-like growth factor binding protein 3; ITT, intention to treat; PP, per protocol.