Denosumab Tied to Infection Risk

Dr. Kristin Criner, Adjunct Clinical Assistant Professor of Medicine at the Lewis Katz School of Medicine at Temple University, Philadelphia, says, “The best data we have to compare this to is the FREEDOM Trial … [which was] the largest randomized control trial comparing denosumab vs. placebo in the prevention of fractures in postmenopausal women with osteoporosis.”²

“Although the primary endpoint was new vertebral fractures at 36 months and secondary endpoints included non-vertebral and hip fractures, there was no significantly higher risk for serious adverse events due to infection in the denosumab group,” she says. “This result held true for the seven-year extension trial.”³

“I have not found an increased incidence of serious adverse events of infection in denosumab-treated patients; however, I am selective in the patients that I choose to use the drug for (i.e., no predisposing risk for infection),” she says. “I think we need a prospective, randomized, controlled trial looking at serious adverse events of infection in denosumab-treated patients as a primary endpoint to see if this meta-analysis really holds true.”

References

1. Diker-Cohen T, Rosenberg D, Avni T, et al. Risk for infections during treatment with denosumab for osteoporosis: A systematic review and meta-analysis. J Clin Endocrinol Metab. 2020 Jan 3. pii: dgz322. [Epub ahead of print]
2. Cummings SR, San Martin J, McClung MR, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009 Aug 20;361(8):756–765. Epub 2009 Aug 11.
3. Bone HG, Wagman RB, Brandi ML, et al. 10 years of denosumab treatment in postmenopausal women with osteoporosis: Results from the phase 3 randomized FREEDOM trial and open-label extension. Lancet Diabetes Endocrinol. 2017 Jul;5(7):513–523. Epub 2017 May 22.