Table 2.
Adverse reaction | Denosumab (n = 3886) | Placebo (n = 3876) |
---|---|---|
Back pain | 1347 (34.7%) | 1340 (34.6%) |
Pain in extremity | 453 (11.7%) | 430 (11.1%) |
Musculoskeletal pain | 297 (7.65) | 291 (7.5%) |
Hypercholesterolemia | 280 (7.2%) | 236 (6.1%) |
Cystitis | 228 (5.9%) | 225 (5.8%) |
Notes: These are listed as “side effects” of denosumab in the Prolia® medication guide43 without explanation regarding statistical significance, causality, or clinical relevance. These untoward medical occurrences are those that are common in elderly populations, with the differences in incidence between the two groups being very small.