Table 1.
Demographics and Baseline Characteristics
| Active (n=130) | Placebo (n=130) | Overall (n=260) | P value1 | |
|---|---|---|---|---|
| Demographics and behavioral | ||||
| Age (years) † | 67.8 (65.1 – 71.5) | 69.0 (65.4 – 73.4) | 68.2 (65.4 – 72.5) | 0.251 |
| Height (cm) | 162.1 ± 6.3 | 162.6 ± 6.8 | 162.3 ± 6.5 | 0.564 |
| Weight(kg) | 78.2 (68.6 – 90.9) | 80 (68.6 – 90.5) | 79.5 (68.6 – 90.9) | 0.790 |
| BMI (kg/m2) † | 30.2 (26.4 – 34.6) | 30.0 (26.8 – 33.9) | 30.1 (26.6 – 34.1) | 0.867 |
| Calcium intake (mg) † | 842.0 (600 – 1142) | 826.5 (628.0 – 1185) | 828.0 (614.0 – 1164) | 0.857 |
| Smoking History, n (%) | 0.805 | |||
| Present | 7 (5.4) | 5 (3.9) | 12 (4.6) | |
| Past | 28 (21.5) | 31 (23.8) | 59 (22.7) | |
| Never | 95 (73.1) | 94 (72.3) | 189 (72.7) | |
| Alcohol History, n (%) | 0.323 | |||
| Present | 72 (55.4) | 83 (63.9) | 155 (59.6) | |
| Past | 2 (1.5) | 2 (1.5) | 4 (1.5) | |
| Never | 56 (43.1) | 45 (34.6) | 101 (38.9) | |
| Bone Mineral Density | ||||
| Total Hip BMD (g/cm2) | 0.919 ± 0.130 | 0.935 ± 0.134 | 0.927 ± 0.132 | 0.329 |
| Total Hip T-score | −0.185 ± 1.065 | −0.054 ± 1.096 | 0.120 ± 1.080 | 0.329 |
| Femoral neck BMD (g/cm2) † | 0.767 (0.694 – 0.9) | 0.805 (0.718 – 0.9) | 0.785 (0.707 – 0.9) | 0.109 |
| Wrist 1/3 BMD (g/cm2) | 0.689 ± 0.067 | 0.692 ± 0.075 | 0.691 ± 0.071 | 0.684 |
| Spine BMD (g/cm2) | 1.005 ± 0.162 | 1.023 ± 0.171 | 1.014 ± 0.167 | 0.396 |
| Whole body BMD (g/cm2) † | 1.127 (1.076 – 1.2) | 1.156 (1.070 – 1.2) | 1.138 (1.070 – 1.2) | 0.222 |
| Femoral Neck Geometry | ||||
| FNW (cm) | 3.254 ± 0.332 | 3.199 ± 0.323 | 3.226 ± 0.328 | 0.174 |
| Composite Indices of FN Strength | ||||
| CSI (g/kg*m) | 3.233 ±0.747 | 3.239±0.608 | 3.236±0.680 | 0.939 |
| BSI (g/kg*m) | 0.107±0.03 | 0.106±0.025 | 0.107 ±0.027 | 0.797 |
| ISI (g/kg*m) | 1.972±0.481 | 1.959±0.403 | 1.965±0.443 | 0.807 |
| Laboratory (serum) | ||||
| 25OHD3, ng/ml | 21.5 ± 6.5 | 22.2 ± 6.9 | 21.8 ± 6.7 | 0.352 |
| PTH (pg/ml) † | 56.1 (41.0 – 73.6) | 56.4 (39.5 – 73.8) | 56.2 (39.8 – 73.8) | 0.977 |
| Ca (mg/dl) † | 9.5 (9.3 – 9.8) | 9.5 (9.3 – 9.8) | 9.5 (9.3 – 9.8) | 0.943 |
| Cr (mg/dl) † | 0.8 (0.7 – 0.9) | 0.7 (0.6 – 0.9) | 0.8 (0.6 – 0.9) | 0.472 |
| P (mg/dl) † | 3.5 (3.2 – 3.8) | 3.5 (3.2 – 3.8) | 3.5 (3.2 – 3.8) | 0.732 |
| CTX (ng/mL) | 0.52 (0.37–0.67) | 0.50 (0.39–0.73) | 0.51 (0.38–0.69) | 0.289 |
| BSAP (mg/L) | 19.88 (16.7–26.1) | 19.45 (15.4–23.3) | 19.6 (16.2–24.4) | 0.078 |
For continuous data, p-values are from Wilcoxon rank-sum test for non-normally distributed variables and two independent samples t-test for normally distributed variables. For categorical variables, p-values are from Fisher’s exact test.
Not normally distributed; IQR=Inter-quartile range (first quartile – third quartile); SD=Standard Deviation
Normally distributed variables were presented as mean ±SD and not normally distributed variables were presented as median (IQR).
25OHD = 25-hydroxyvitamin D; BMD = bone mineral density; BMI = Body Mass Index; BSAP = bone specific alkaline phosphatase; BSI = bending strength index; CTX = cross-linked C-telopeptide; CSI = compression strength index; FNW = FN width; ISI = impact strength index; PTH = parathyroid hormone