Table 2.
Baseline Visit | Study End | Treatment Effect | |||||
---|---|---|---|---|---|---|---|
Median | IQR | Median | IQR | Between Group Differences with 95% CI | p-Value | ||
Mineral metabolism | |||||||
25-hydroxyvitamin D (nmol/L) | |||||||
Vitamin D (n = 96) | 53 | 43–68 | 98 | 85–116 | 37.4 | 31.3 to 43.6 | <0.001 |
Placebo (n = 96) | 52 | 42–64 | 65 | 51–77 | |||
PTH (pg/mL) | |||||||
Vitamin D (n = 94) | 46.6 | 36.2–57.0 | 46.4 | 35.0–59.2 | −4.8 | −8.9 to −0.8 | 0.021 |
Placebo (n = 95) | 43.4 | 35.8–54.3 | 49.3 | 38.7–61.6 | |||
Bone turnover markers | |||||||
CTX (nmol/L) | |||||||
Vitamin D (n = 94) | 0.40 | 0.27–0.50 | 0.36 | 0.23–0.48 | −0.01 | −0.04 to 0.03 | 0.792 |
Placebo (n = 96) | 0.35 | 0.27–0.50 | 0.36 | 0.27–0.45 | |||
Osteocalcin (ng/mL) | |||||||
Vitamin D (n = 94) | 20.9 | 16.7–25.5 | 21.5 | 17.6–27.8 | 0.84 | −0.76 to 2.44 | 0.300 |
Placebo (n = 96) | 21.2 | 16.8–24.3 | 20.3 | 17.7–23.9 | |||
BMD | |||||||
Total body BMD (g/cm2) | |||||||
Vitamin D (n = 94) | 1.294 | 1.221–1.369 | 1.300 | 1.239–1.366 | 0.006 | −0.006 to 0.020 | 0.293 |
Placebo (n = 92) | 1.299 | 1.234–1.360 | 1.295 | 1.225–1.368 | |||
Lumbar spine BMD (g/cm2) | |||||||
Vitamin D (n = 94) | 1.233 | 1.106–1.334 | 1.227 | 1.100–1.345 | 0.002 | −0.009 to 0.012 | 0.760 |
Placebo (n = 92) | 1.213 | 1.110–1.315 | 1.219 | 1.099–1.326 | |||
Femoral neck BMD (g/cm2) | |||||||
Vitamin D (n = 94) | 1.027 | 0.932–1.143 | 1.037 | 0.928–1.141 | 0.002 | −0.006 to 0.011 | 0.637 |
Placebo (n = 92) | 1.022 | 0.956–1.120 | 1.012 | 0.943–1.113 | |||
Total hip BMD (g/cm2) | |||||||
Vitamin D (n = 94) | 1.073 | 0.993–1.184 | 1.075 | 0.984–1.177 | −0.002 | −0.009 to 0.006 | 0.662 |
Placebo (n = 92) | 1.076 | 1.002–1.156 | 1.067 | 1.002–1.165 | |||
TBS | |||||||
Vitamin D (n = 53) | 1.357 | 1.313–1.521 | 1.375 | 1.273–1.484 | 0.037 | −0.102 to 0.176 | 0.596 |
Placebo (n = 55) | 1.382 | 1.351–1.445 | 1.378 | 1.319–1.418 |
IQR = interquartile range, PTH = parathyroid hormone, CTX = beta-crosslaps, BMD = bone mineral density, TBS = trabecular bone score. Data are shown as medians and interquartile range. Treatment effects with 95% confidence interval and p-values were calculated by ANCOVA for group differences at follow-up with adjustment for baseline values.