Table 5.
Small differences in bone health between prednisolone-treated and placebo-treated patients after 2 years
| Prednisolone | Placebo | |||||
| Baseline | Change | Baseline | Change | Difference | p | |
| Bone mineral density* n | 220 | 142 | 221 | 135 | ||
| Lumbar spine | ||||||
| g/cm2 | 1.06 (0.21) | –0.01 (0.08) | 1.03 (0.19) | 0.03 (0.08) | 0.04 (0.02) | < 0.0001 |
| T–score | –0.48 (1.70) | –0.07 (0.58) | –0.71 (1.60) | 0.19 (0.63) | 0.27 (0.15) | |
| Total hip | ||||||
| g/cm2 | 0.85 (0.14) | 0.00 (0.11) | 0.86 (0.16) | 0.00 (0.05) | 0.00 (–0.02) | 0.40 |
| T–score | –1.14 (0.99) | –0.04 (0.59) | –1.09 (1.06) | –0.01 (0.37) | –0.04 (0.06) | |
| Fracture† n | 211 | 120 | 220 | 124 | relative risk | |
| Spine compression (imaging) |
68 (32) | 23 (19) | 78 (36) | 19 (15) | 1.28 (0.88) | 0.14 |
| n | 224 | 225 | ||||
| SAE | other AESI | SAE | other AESI | |||
| Symptomatic, total‡ | 2 | 11 | 4 | 6 | ||
| Vertebral | 0 | 4 | 2 | 2 | ||
| Pelvis | 2 | 1 | 0 | 0 | ||
| Hip | 0 | 0 | 1 | 0 | ||
| Foot | 0 | 4 | 0 | 1 | ||
| Arm/hand | 0 | 2 | 0 | 3 | ||
| Multiple limb | 0 | 0 | 1 | 0 | ||
* Mean (SD); and mean difference (1–sided 95%confidence bound).
† Count (%); change means patients with ≥1 new fracture or increase in grade.
‡ Count only.
AESI, adverse event of special interest; comprises serious adverse events (SAE) and 'other AESI'; relative risk, is adjusted (95% CL).