TABLE 1.
Demographics and baseline characteristics.
| Placebo (N = 10) | SHR-1222 | ||||||
|---|---|---|---|---|---|---|---|
| 50 mg (N = 4) | 100 mg (N = 9) | 200 mg (N = 9) | 300 mg (N = 9) | 400 mg (N = 9) | All (N = 40) | ||
| Age, year, mean (SD) | 50.8 (2.9) | 50.0 (2.0) | 51.9 (4.3) | 52.4 (3.1) | 51.7 (2.6) | 50.3 (3.8) | 51.4 (3.4) |
| Sex, n (%) | |||||||
| Men | 5 (50.0) | 2 (50.0) | 3 (33.3) | 3 (33.3) | 3 (33.3) | 3 (33.3) | 14 (35.0) |
| Women | 5 (50.0) | 2 (50.0) | 6 (66.7) | 6 (66.7) | 6 (66.7) | 6 (66.7) | 26 (65.0) |
| BMI, kg/m2, mean (SD) | 23.51 (1.98) | 23.90 (2.38) | 23.20 (1.44) | 22.82 (1.47) | 21.67 (2.18) | 23.20 (2.61) | 22.84 (2.04) |
| Lumbar spine L1-L4 BMD, median (min, max) | 0.862 (0.735, 1.062) | 0.918 (0.764, 0.961) | 0.918 (0.820, 1.040) | 0.879 (0.776, 0.993) | 0.839 (0.752, 1.011) | 0.826 (0.731, 1.041) | 0.882 (0.731, 1.062) |
| Femoral neck BMD, median (min, max) | 0.758 (0.617, 0.968) | 0.753 (0.681, 0.864) | 0.743 (0.589, 0.822) | 0.692 (0.562, 0.834) | 0.750 (0.635, 0.875) | 0.738 (0.576, 0.812) | 0.740 (0.562, 0.968) |
| Total hip BMD, median (min, max) | 0.853 (0.756, 1.107) | 0.858 (0.771, 1.013) | 0.875 (0.689, 1.083) | 0.804 (0.533, 0.970) | 0.912 (0.744, 0.999) | 0.858 (0.721, 0.987) | 0.865 (0.533, 1.107) |
| Lumbar spine L1-L4 T-score, median (min, max) | −1.15 (−2.3, 0.7) | −0.65 (−1.9, −0.3) | −0.60 (−1.5,0.4) | −0.90 (−1.8, 0.0) | −1.30 (−2.0, 0.2) | −1.40 (−2.2, 0.4) | −0.90 (−2.3, 0.7) |
| Femoral neck T-score, median (min, max) | −0.75 (−2.0, 1.2) | −0.80 (−1.3, 0.1) | −1.10 (−2.1, −0.1) | −1.20 (−2.4, 0.1) | −0.60 (−1.9, 0.2) | −1.00 (−2.2, −0.1) | −0.95 (−2.4, 1.2) |
| Total hip T-score, median (min, max) | −0.45 (−1.7, 1.5) | −0.50 (−1.0, 0.6) | −0.10 (−1.7, 1.2) | −0.90 (−3.0, 0.7) | 0.10 (−1.2, 0.6) | −0.30 (−1.5, 0.8) | −0.50 (−3.0, 1.5) |
BMI, body−mass index; BMD, bone mineral density.