Table 1.
Baseline Characteristics
| Long-term denosumab treatment, Extension subjects (N = 2343) | Cross-over denosumab treatment, Extension subjects (N = 2207) | |||
|---|---|---|---|---|
| FREEDOM baseline | Extension baseline | FREEDOM baseline | Extension baseline | |
| Age (years) | 71.9 (5.0) | 74.9 (5.0) | 71.8 (5.1) | 74.8 (5.1) |
| Age groups, n (%) | ||||
| ≥65 years | 2209 (94.3) | 2294 (97.9) | 2067 (93.7) | 2149 (97.4) |
| ≥75 years | 662 (28.3) | 1258 (53.7) | 624 (28.3) | 1151 (52.2) |
| Years since menopause | 23.7 (7.3) | 26.7 (7.3) | 23.7 (7.4) | 26.7 (7.4) |
| Prevalent vertebral fractures, n (%) | 559 (23.9) | 573 (24.5) | 485 (22.0) | 551 (25.0) |
| Lumbar spine BMD T-score | −2.83 (0.67) | −2.14 (0.80) | −2.84 (0.68) | −2.81 (0.75) |
| Total hip BMD T-score | −1.85 (0.79) | −1.50 (0.79) | −1.85 (0.79) | −1.93 (0.80) |
| CTXa (ng/mL), median (IQR) | 0.524 (0.363–0.710) | 0.183 (0.081–0.556) | 0.554 (0.420–0.657) | 0.568 (0.413–0.718) |
| P1NPa (µg/L), median (IQR) | 46.7 (34.0–58.2) | 17.5 (11.0–26.0) | 54.2 (40.0–65.7) | 48.8 (35.0–65.8) |
Data are mean with standard deviations (SD) unless otherwise noted.
BMD = bone mineral density; CTX = C-terminal telopeptide of type 1 collagen; IQR = interquartile range; N = number of subjects enrolled in the extension; P1NP = procollagen type I N-terminal propeptide.
a
BTM subsets include 65 subjects in the long-term group and 36 subjects in the cross-over group.