Table 3.
Areal BMD gm/cm2 and areal BMD z-scores over during the course of the study (population: ITT).
| N, mean (SD) |
|||
|---|---|---|---|
| Placebo | Alfacalcidol | Risedronate | |
| Lumbar Spine aBMD g/cm2 | |||
| Screening | 76, 0.76 (0.20) | 71, 0.79 (0.21) | 68, 0.78 (0.19) |
| 6 month | 68, 0.79 (0.18) | 63, 0.80 (0.22) | 59, 0.82 (0.19) |
| One-year | 72, 0.80 (0.19) | 67, 0.83 (0.21) | 58, 0.85 (0.17) |
| Lumbar spine aBMD z score | |||
| Screening | 76, − 1.15 (1.15) | 68, − 0.91 (1.04) | 66, − 1.04 (1.17) |
| Screening-calculateda | 76, − 1.15 (1.15) | 71, − 0.96 (1.04) | 68, − 0.99 (1.19) |
| 6 month | 68, − 1.17 (1.07) | 61, − 0.95 (1.12) | 57, − 0.84 (1.16) |
| 6 month-calculateda | 68, − 1.17 (1.07) | 63, − 1.01 (1.15) | 59, − 0.79 (1.18) |
| One-year | 72, − 1.13 (1.10) | 67, − 0.99 (1.07) | 58, − 0.74 (1.17) |
| One-year-calculateda | 72, − 1.13 (1.10) | 67, − 1.00 (1.07) | 58, − 0.75 (1.15) |
| Total body less head aBMD g/cm2 | |||
| Screening | 75, 0.91 (0.14) | 70, 0.93 (0.16) | 68, 0.91 (0.13) |
| 6 month | 68, 0.93 (0.13) | 62, 0.94 (0.17) | 58, 0.93 (0.13) |
| One-year | 70, 0.92 (0.12) | 65, 0.97 (0.16) | 59, 0.96 (0.13) |
| Total body less head aBMD z score | |||
| Screening | 75, − 0.57 (0.99) | 67, − 0.4 (1.09) | 66, − 0.63 (1.08) |
| Screening-calculateda | 75, − 0.57 (0.99) | 70, − 0.63 (1.64) | 68, − 0.65 (1.08) |
| 6 month | 68, − 0.62 (0.99) | 59, − 0.29 (1.19) | 56, − 0.50 (1.08) |
| 6 month-calculateda | 68, − 0.62 (0.99) | 62, − 0.49 (1.55) | 58, − 0.52 (1.08) |
| One-year | 70, − 0.70 (0.94) | 65, − 0.46 (1.28) | 59, − 0.46 (1.09) |
| One-year-calculateda | 70, − 0.70 (0.94) | 65, − 0.57 (1.47) | 59, − 0.44 (1.08) |
Least Median Squares (LMS) method [22].
a
Includes z-scores for five patients (all visits) who were below five years of age that were calculated using.