Table 2.
Denosumab Treatment Effect on Total Hip BMD, and New or Worsening Vertebral and Nonvertebral Fracture Risk at 12, 24, and 36 Months
| BMD | Fracture | |||||
|---|---|---|---|---|---|---|
| Mean (CI) | Difference Mean (CI) | New or worsening vertebral na | New or worsening vertebral RR (CI) | Nonvertebral nb | Nonvertebral HR (CI) | |
| Month 12 | ||||||
| Placebo | 0.0 (−0.1, 0.1) | 3.3 (3.1, 3.4) | 82 | 0.39 (0.26, 0.58) | 117 | 0.84 (0.65, 1.11) |
| Denosumab | 3.2 (3.1, 3.3) | 32 | 99 | |||
| Month 24 | ||||||
| Placebo | −0.7 (−0.8, −0.6) | 5.1 (4.9, 5.2) | 183 | 0.29 (0.21, 0.39) | 214 | 0.79 (0.64, 0.96) |
| Denosumab | 4.4 (4.3, 4.5) | 53 | 170 | |||
| Month 36 | ||||||
| Placebo | −1.4 (−1.5, −1.3) | 6.4 (6.2, 6.6) | 264 | 0.32 (0.26, 0.41) | 293 | 0.80 (0.67, 0.95) |
| Denosumab | 5.0 (4.9, 5.1) | 86 | 238 | |||
n = number of subjects with ≥1 fracture; CI = 95% confidence interval; RR = risk ratio; HR = hazard ratio.
a
There were 3691 women in the placebo group and 3702 in the denosumab group who were evaluable for new or worsening vertebral fractures.
b
There were 3906 women in the placebo group and and 3902 women in the denosumab group who were evaluable for nonvertebral fractures.Difference and ratios reference placebo.