Table 1.
Summary of subject data used in the modeling and simulation
| Zoledronic acid (N = 145) | Placebo (N = 161) | Total (N = 306) | |
|---|---|---|---|
| Sex | |||
| Male | 11 (7.6%) | 6 (3.7%) | 17 (5.6%) |
| Female | 134 (92.4%) | 155 (96.3%) | 289 (94.4%) |
| Age (years) | 72.9 ± 5.2 [65–86] |
72.9 ± 5.3 [65–87] |
72.9 ± 5.2 [65–87] |
| Weight (kg) | 51.4 ± 7.4 [36.0–76.4] |
53.1 ± 8.4 [34.1–83.6] |
52.3 ± 8.0 [34.1–83.6] |
| Prior usage of bisphosphonate | |||
| Never used | 132 (91.0%) | 145 (90.0%) | 277 (90.5%) |
| Used with sufficient washout | 13 (9.0%) | 16 (10.0%) | 29 (9.5%) |
| TRACP-5b (mU/dL) | 398.0 ± 143.6 [183–1240] |
403.9 ± 152.0 [157–1030] |
401.1 ± 147.9 [157–1240] |
| CTx (ng/mL) | 0.406 ± 0.175 [0.08–1.00] |
0.404 ± 0.190 [0.10–0.99] |
0.405 ± 0.183 [0.08–1.00] |
| u-NTx (nMBCE/mMCr.) | 54.52 ± 21.43 [16.4–119.0] |
54.97 ± 25.69 [14.0–150.0] |
54.76 ± 23.73 [14.0–150.0] |
| Lumbar spine T-score (L2-L4) | − 2.769 ± 0.800 [− 5.51 to − 0.68] |
− 2.829 ± 0.791 [− 5.25 to − 0.25] |
− 2.801 ± 0.795 [− 5.51 to − 0.25] |
| Lumbar spine BMD (L2-L4) (g/cm2) | 0.680 ± 0.095 [0.36–0.93] |
0.674 ± 0.094 [0.39–0.98] |
0.677 ± 0.094 [0.36–0.98] |
Values are expressed as means ± SD [range]
TRACP-5b tartrate-resistant acid phosphatase 5b, CTx C-telopeptide of type I collagen, u-NTx urinary N-telopeptide of type I collagen, BMD bone mineral density