Table 1.
Description of the Double‐blind Denosumab Versus Placebo‐controlled Studies Included in the Present Analysis
| Trial | Study population | No. of subjects (placebo/denosumab) | Age (years) (placebo/denosumab), mean (SD) | All adverse events (placebo/denosumab), n (%) | Denosumab exposure, months | Reference |
|---|---|---|---|---|---|---|
| Osteoporosis | ||||||
| 1 | Postmenopausal osteoporosis | 3876/3886 | 72.3 (5.2)/72.3 (5.2) | 3607 (93.1)/3605 (92.8) | 36 | 10 |
| 2 | Postmenopausal women with low bone mass | 165/164 | 58.9 (7.5)/59.8 (7.4) | 157 (95.2)/156 (95.1) | 24 | 17 |
| 3 | Men with osteoporosis | 120/120 | 65.1 (9.2)/65.0 (10.2) | 87 (73)/87 (73) | 12 | 18 |
| Cancer treatment‐induced bone loss (CTIBL) | ||||||
| 4 | Women with aromatase inhibitor therapy for breast cancer | 120/129 | 59.7 (9.7)/59.2 (8.9) | 108 (90)/117 (90.7) | 24 | 19 |
| 5 | Men with androgen‐deprivation therapy for prostate cancer | 725/731 | 75.5 (7.1)/75.3 (7.0) | 627 (86.5)/638 (87.3) | 36 | 20 |