Table 1.
Study subject characteristics
| Characteristic | Pbo-P | TPTD-P 20-μg | TPTD-P 30-μg | TPTD-P 40-μg | TPTD-I 20-μg |
|---|---|---|---|---|---|
| n | 33 | 34 | 32 | 33 | 33 |
| Age (yr) | 64.8 (7.1) | 64.1 (7.5) | 63.6 (5.8) | 64.6 (7.3) | 63.2 (6.8) |
| Weight (kg) | 63.2 (9.4) | 59.1 (9.2) | 58.6 (7.8) | 62.0 (9.9) | 63.0 (9.5) |
| Height (cm) | 154 (6.2) | 152 (7.3) | 154 (6.8) | 156 (7.5) | 152 (7.7) |
| Race (%)a | |||||
| Caucasian | 12.1 | 26.5 | 31.3 | 42.4 | 24.2 |
| Hispanic | 87.9 | 73.5 | 68.8 | 57.6 | 72.7 |
| Asian | 3 | ||||
| Vertebral fractures | 8 | 6 | 4 | 7 | 8 |
| T-score | |||||
| LS | −3.2 (0.7) | −3.0 (0.5) | −3.2 (0.5) | −3.2 (0.7) | −3.0 (0.6) |
| Total hip | −1.6 (0.7) | −1.5 (0.7) | −1.7 (0.5) | −1.8 (0.7) | −1.7 (0.6) |
| BMD (gm/cm2) | |||||
| LS | 0.71 (0.1) | 0.74 (0.1) | 0.72 (0.1) | 0.74 (0.1) | 0.74 (0.1) |
| Total hip | 0.70 (0.1) | 0.70 (0.09) | 0.74 (0.1) | 0.73 (0.1) | 0.75 (0.1) |
| Femoral neck | 0.60 (0.1) | 0.60 (0.1) | 0.63 (0.1) | 0.64 (0.1) | 0.65 (0.1) |
| Biomarkers | |||||
| P1NP (ng/ml) | 49.5 (19.4) | 45.7 (22.0) | 43.9 (17.6) | 42.2 (19.6) | 45.8 (19.1) |
| CTX (ng/ml) | 0.60 (0.3) | 0.62 (0.3) | 0.63 (0.2) | 0.65 (0.4) | 0.65 (0.3) |
| Total serum calcium (mg/dl) | 9.4 (0.5) | 9.6 (0.5) | 9.3 (0.5) | 9.5 (0.5) | 9.6 (0.4) |
All values are expressed as mean (sd) unless otherwise stated.
a
There was no statistical difference among any of the groups. For race, P < 0.1.