Table 5.
Antropometric, bone and metabolic changes at pre-specified time point.
| Pretreatment | 12th week | 25th week | 1 month after enza | P-value | |
|---|---|---|---|---|---|
| Body Mass Index | (n = 50) | (n = 46) | (n = 40) | (n = 40) | |
| Mean ± SD | 28.30 ± 4.55 | 27.55 ± 4.83 | 27.30 ± 4.18 | 27.38 ± 4.11 | Pre vs 12th w: p <0.0001 |
| (range) | (17.03–44.39) | (16.78–44.46) | (17.32–40.04) | (20.57–40.57) | Pre vs 25thw: p = 0.001 |
| 95% CI | 27.04–29.56 | 26.16–28.95 | 26.01–28.60 | 26.11–28.66 | Pre vs 1 m: p = 0.082 |
| Bone Density Femoral Neck (g/cm2) | (n = 45) | (n = 45) | |||
| Mean ± SD | 0.85 ± 0.15 | 0.86 ± 0.15 | Pre vs 25th w: p = 0.253 | ||
| (range) | (0.58–1.35) | (0.61–1.25) | |||
| 95% CI | 0.80–0.89 | 0.82–0.91 | |||
| Bone Density Lumbar Spine (g/cm2) | (n = 48) | (n = 48) | |||
| Mean ± SD | 1.13 ± 0.21 | 1.14 ± 0.21 | Pre vs 25th w: p = 0.342 | ||
| (range) | (0.77–1.87) | (0.77–1.92) | |||
| 95% CI | 1.07–1.19 | 1.08–1.20 | |||
| Alkaline Phosphatase (U/L) | (n = 49) | (n = 44) | (n = 49) | ||
| Mean ± SD | 72.61 ± 27.65 | 65.48 ± 17.63 | 76.59 ± 25.78 | Pre vs 12thw: p = 0.033 Pre vs 25thw: p = 0.093 |
|
| (range) | (39.00–226.00) | (38.00–139.00) | (36.00–186.00) | ||
| 95% CI | 64.87–80.36 | 60.27–70.69 | 69.37–83.81 | ||
| Fasting Glucose (mg/dl) | (n = 54) | (n = 46) | (n = 50) | (n = 50) | |
| Mean ± SD | 113.67 ± 31.71 | 113.43 ± 28.76 | 115.68 ± 31.95 | 117.94 ± 32.22 | Pre vs 12thw: p = 0.881 |
| (range) | (83.00–253.00) | (70.00–253.00) | (83.00–247.00) | (80.00–263.00) | Pre vs 25thw: p = 0.886 |
| 95% CI | 105.21–122.12 | 105.12–121.75 | 106.82–124.53 | 108.01–125.87 | Pre vs 1 m: p = 0.758 |
| Fasting Cholesterol Total (mg/dl) | (n = 38) | (n = 24) | (n = 37) | ||
| Mean ± SD | 185.58 ± 40.56 | 189.88 ± 34.69 | 198.44 ± 38.42 | Pre vs 12thw: p = 0.218 | |
| (range) | (114.00–277.00) | (117.00–254.00) | (102.00–269.00) | Pre vs 25thw: p = 0.054 | |
| 95% CI | 172.69–198.48 | 176.00–203.75 | 186.06–210.82 | ||
| Fasting Cholesterol HDL (mg/dl) | (n = 33) | (n = 21) | (n = 32) | ||
| Mean ± SD | 54.19 ± 22.46 | 49.72 ± 10.30 | 58.37 ± 22.12 | Pre vs 12thw: p = 0.382 | |
| (range) | (34.00–162.00) | (34.00–69.00) | (41.00–162.00) | Pre vs 25thw: p = 0.015 | |
| 95% CI | 46.52–61.85 | 45.31–54.12 | 50.71–66.03 | ||
| Fasting Cholesterol LDL (mg/dl) | (n=33) | (n = 20) | (n = 32) | ||
| Mean ± SD | 109.34±40.64 | 108.08 ± 30,33 | 116.37 ± 30.64 | Pre vs 12thw: p = 0.409 | |
| (range) | (16.00-197.00) | (57.00–173.00) | (70.00–174.00) | Pre vs 25thw: p = 0.220 | |
| 95% CI | 95.47-123.20 | 94.79–121.37 | 105.75–126.98 | ||
| Fasting Triglicerides (mg/dl) | (n = 38) | (n = 20) | (n = 38) | ||
| Mean ± SD | 130.22 ± 55.97 | 142.78 ± 61.16 | 136.85 ± 56.90 | Pre vs 12thw: p = 0.971 | |
| (range) | (54.00–265.00) | (54.00–313.00) | (56.00–301.00) | Pre vs 25thw: p = 0.165 | |
| 95% CI | 112.42–148.02 | 119.71–165.85 | 118.49–154.68 |