Table 2.
Adverse Events
| Placebo (n = 83) | Alendronate 70 mg qw (n = 81) | Denosumab 60 mg q6m (n = 83) | |
|---|---|---|---|
| Adverse events, n (%) | 78 (94.0) | 77 (95.1) | 76 (91.6) |
| AEs occurring with ≥10% frequency | |||
| Constipation | 12 (14.5) | 13 (16.0) | 15 (18.1) |
| Influenza | 15 (18.1) | 10 (12.3) | 14 (16.9) |
| Pain in extremity | 10 (12.0) | 10 (12.3) | 10 (12.0) |
| Nasopharyngitis | 14 (16.9) | 8 (9.9) | 10 (12.0) |
| Arthralgia | 8 (9.6) | 8 (9.9) | 10 (12.0) |
| Back pain | 10 (12.0) | 6 (7.4) | 10 (12.0) |
| Bronchitis | 11 (13.3) | 11 (13.6) | 9 (10.8) |
| Headache | 9 (10.8) | 12 (14.8) | 6 (7.2) |
| Upper abdominal pain | 8 (9.6) | 10 (12.3) | 5 (6.0) |
| Dyspepsia | 7 (8.4) | 9 (11.1) | 5 (6.0) |
| Diarrhea | 9 (10.8) | 10 (12.3) | 3 (3.6) |
| Abdominal pain | 3 (3.6) | 9 (11.1) | 2 (2.4) |
| Treatment‐related adverse eventsa | 32 (38.6) | 36 (44.4) | 26 (31.3) |
| Serious adverse events, n (%) | 5 (6.0) | 5 (6.2) | 2 (2.4) |
| Acute cholecystitis | 0 (0.0) | 0 (0.0) | 1 (1.2) |
| Loss of consciousness | 0 (0.0) | 1 (1.2) | 1 (1.2)b |
| Hyperglycemia | 0 (0.0) | 0 (0.0) | 1 (1.2)b |
| Breast cancer | 0 (0.0) | 2 (2.5) | 0 (0.0) |
| Adenocarcinoma of the cervix | 0 (0.0) | 1 (1.2) | 0 (0.0) |
| Biliary colic | 0 (0.0) | 1 (1.2) | 0 (0.0) |
| Cholelithiasis | 2 (2.4) | 0 (0.0) | 0 (0.0) |
| Amnesia | 1 (1.2) | 0 (0.0) | 0 (0.0) |
| Confusional state | 1 (1.2) | 0 (0.0) | 0 (0.0) |
| Pneumonia | 1 (1.2) | 0 (0.0) | 0 (0.0) |
a
Assessed by the investigator as being possibly or probably related to investigational product administration without unblinding of treatment.
b
One subject in the denosumab group had two serious adverse events (hyperglycemia and loss of consciousness), neither of which was considered related to study treatment.