Table 4.
Safety data at 12 months
| Outcome | Germany (N = 599) | Austria (N = 300) | Greece (N = 300) | Belgium (N = 301) |
|---|---|---|---|---|
| All adverse drug reactions | 30 (5.0) | 8 (2.7) | 8 (2.7) | 5 (1.7) |
| Leading to discontinuation of denosumab | 15 (2.5) | 2 (0.7) | 1 (0.3) | 2 (0.7) |
| Serious adverse drug reaction | 3 (0.5) | 0 (0.0) | 0 (0.0) | 1 (0.3) |
| Leading to death | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Adjudicated positive ONJ | 2 (0.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Osteoporotic fracturea | 10 (1.7) | 2 (0.7) | 7 (2.3) | 8 (2.7) |
| Adjudicated positive for atypical femoral fracture | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Delayed fracture healing | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Data are shown as n (%)
ONJ osteonecrosis of the jaw
aOsteoporotic fractures were defined as all fractures excluding those of the skull, facial bones, mandible, metacarpus, finger phalanges, toe phalanges, and cervical vertebrae and those not associated with known high trauma severity (fall from higher than the height of stool, chair, or first rung on a ladder or equivalent [>20 in.], or severe trauma other than a fall) and pathological fractures