Table 2. Subject Baseline Characteristics (ITT Population of Double-Blind Phase).
| Variable | Denosumab (n=69) | Placebo (n=66) |
|---|---|---|
| Age, mean±SD (range) | 67.0±4.86 (60-81) | 66.0±4.77 (60-78) |
| Height, cm, mean±SD | 152.2±4.94 | 154.3±5.25 |
| Weight, kg, mean±SD | 54.4±6.68 | 56.5±6.31 |
| BMI, kg/m2, mean±SD (range) | 23.5±2.83 (14.0-30.0) | 23.7±2.29 (18.9-27.9) |
| Years since menopause, mean±SD | 19.0±7.02 | 17.5±6.20 |
| Previous fracture*, n (%) | 21 (30) | 15 (23) |
| Parent history of hip fracture, n (%) | 1 (1) | 5 (8) |
| Corrected T-score, mean±SD | ||
| Femoral neck | -2.5±0.56 | -2.4±0.61 |
| Total hip | -2.0±0.64 | -1.9±0.65 |
| Total spine | -3.0±0.59 | -2.9±0.58 |
| Trochanter | -2.2±0.63 | -2.2±0.66 |
| s-CTX, µg/L, mean±SD | 0.611±0.2975 | 0.537±0.2421 |
| s-PINP, µg/L, mean±SD | 60.2±25.17 | 57.7±25.90 |
| 10-yr probability (%) of hip fracture† | ||
| Hologic | 4.9±4.40 | 4.8±3.47 |
| Lunar | 3.9±2.79 | 3.9±3.56 |
| 10-yr probability (%) of major osteoporotic fracture† | ||
| Hologic | 11.4±6.54 | 11.6±4.53 |
| Lunar | 10.2±4.46 | 10.2±6.00 |
BMD, bone mineral density; BMI, body mass index; ITT, intent to treat; SD, standard deviation; s-CTX, serum C-terminal telopeptide of type I collagen; s-PINP, serum procollagen type I N-terminal propeptide.
*Most common was prior wrist fracture (6 in denosumab group and 4 in placebo group), †Fracture probability was calculated using screening femoral neck BMD assessments in the World Health Organization's Fracture Risk Assessment Tool (FRAX) model.