Table 2.
Incidence of adverse events from months 48 to 72
| No further active treatment (N = 51)a n (%) | Zoledronate 5 mg IV single dose(N = 87)b n (%) | |
|---|---|---|
| All adverse events | 37 (72.5) | 73 (83.9) |
| Serious adverse events | 8 (15.7) | 12 (13.8) |
| Death | 1 (2.0) | 0 |
| Leading to study discontinuation | 0 | 0 |
| Adverse events of interest | ||
| Osteoarthritis | 5 (9.8) | 7 (8.0) |
| Potentially associated with hypersensitivity | 3 (5.9) | 3 (3.4) |
| Malignancies | 0 | 2 (2.3) |
| Hyperostosis | 0 | 0 |
| Hypocalcemia | 0 | 0 |
| Osteonecrosis of the jawc | 0 | 0 |
| Atypical femoral fracturec | 0 | 0 |
| Fragility fractured | 2 (3.9) | 2 (2.3) |
N = number of subjects in follow-on phase who did or did not receive at least 1 dose of zoledronate
n = number of subjects reporting at least 1 event
No further active treatment: Subjects randomized to romosozumab (any dose or schedule) in the month 0 to 24 double-blind period, received denosumab 60 mg Q6M in the month 24 to 36 extension period, received a second course of romosozumab 210 mg QM from months 36 to 48, and received no further active treatment from months 48 to 72
Zoledronate 5 mg IV single dose: Subjects randomized to romosozumab (any dose or schedule) or placebo in the month 0 to 24 double-blind period, received denosumab or placebo in the month 24 to 36 extension period, received a second course of romosozumab 210 mg QM from months 36 to 48, and received a single IV dose of zoledronate 5 mg from months 48 to 72
aIncludes all subjects who enrolled in the month 48 to 72 follow-on phase assigned to no further active treatment (including 1 subject who had been randomized to placebo in the initial 24 months and was incorrectly assigned to no further active treatment)
bData not shown for 3 subjects who were assigned to zoledronate at month 48 but did not receive treatment
cPotential cases of osteonecrosis of the jaw and atypical femoral fracture were adjudicated by independent committees
dNo further active treatment group: 1 radius and 1 fibula fracture; zoledronate group: 1 radius and 1 rib fracture
IV intravenous, QM every month, Q6M every 6 months