Table 3:
Vamorolone dose |
Biomarker |
Visit |
N | Mean | SD |
Paired t-test p-value |
0.25 mg/kg/day |
Osteocalcin (ng/mL) |
Baseline | 12 | 37.9 |
11.6 | ns |
Week 2 | 12 | 38.5 |
12 | |||
CTX (pg/mL) |
Baseline | 11 | 871 |
161 | ns | |
Week 2 | 12 | 964 |
158 | |||
P1NP (ng/mL) |
Baseline | 12 | 556 |
185 | 0.01 | |
Week 2 | 12 | 444 |
93.9 | |||
0.75 mg/kg/day |
Osteocalcin (ng/mL) | Baseline | 8 | 34.8 |
7.7 | ns |
Week 2 | 10 | 34.8 | 9.1 | |||
CTX (pg/mL) | Baseline | 8 | 915 | 281 | ns | |
Week 2 | 10 | 913 | 276 | |||
P1NP (ng/mL) | Baseline | 8 | 472 | 121 | ns | |
Week 2 | 10 | 417 | 98.5 | |||
2.0 mg/kg/day |
Osteocalcin (ng/mL) | Baseline | 10 | 40.8 | 6.13 | ns |
Week 2 | 10 | 36.5 | 9.16 | |||
CTX (pg/mL) | Baseline | 10 | 905 | 265 | 0.006 | |
Week 2 | 10 | 675 | 172 | |||
P1NP (ng/mL) | Baseline | 10 | 519 | 96 | <0.001 | |
Week 2 | 10 | 341 | 72.9 | |||
6.0 mg/kg/day |
Osteocalcin (ng/mL) | Baseline | 10 | 44.8 | 6.33 | <0.001 |
Week 2 | 10 | 29.9 | 4.69 | |||
CTX (pg/mL) | Baseline | 10 | 904 | 203 | <0.001 | |
Week 2 | 10 | 649 | 205 | |||
P1NP (ng/mL) | Baseline | 10 | 516 | 116 | <0.001 | |
Week 2 | 10 | 310 | 59 |