411 Prolia/Denosumab--Osteoporosis Medication

[Rod Hagen]

What is your personal experience with, or knowledge of, this Osteoporosis or severe Osteopenia, injectable (efficacy, adverse effects, etc.)?  Asking for friend. Thank you. 
 

p.s. Iam grateful for the responses within, and will update, my other 411 health threads.

Edited May 3, 2023 by Rod Hagen

[Guest]

Well, I don't know if your friend is a man, but there really is no evidence of which I'm aware that denosumab is effective in men (only approved for postmenopausal osteoporosis). 

Osteoporosis Treatment Efficacy for Men: A Systematic Review and Meta-Analysis - PMC

WWW.NCBI.NLM.NIH.GOV

---

Osteoporosis affects approximately 2 million men in the U.S., however, few osteoporosis clinical studies include men. The objective of this study was to evaluate the...

 

"...Our meta-analysis findings for individual treatment options demonstrated that alendronate and risedronate significantly reduce risk of vertebral fracture for men; however, our meta-analyses for individual treatment options did not demonstrate evidence of statistically significant reduction in vertebral fracture risk for men with calcitonin or denosumab, nonvertebral fracture risk for men with alendronate, or clinical fracture risk for men with zoledronic acid..."

Another meta-analysis looking at safety showed that this medication significantly increases risk of infections, so I wouldn't recommend it as a first-line treatment, nor just for "severe osteopenia":

Safety of denosumab in postmenopausal women with osteoporosis or low bone mineral density: a meta-analysis - PMC

WWW.NCBI.NLM.NIH.GOV

---

Purpose: The aim of this meta-analysis was to assess the safety of denosumab in postmenopausal women with osteoporosis or low bone mineral density (BMD)...

 

"...A concern regarding the long-term use of denosumab relates to its possible effects on the immune system, increasing the risk of infections and cancer [27,31]. In this meta-analysis, the result showed the increase in the risk of SAE related to infection. However, no significant effect on the risk of cancer was found...". (SAE means significant adverse events)

The only other caveat I'd add is that it's difficult to document an absence of cancer risk, since the cancer risk would be mainly seen many years, maybe even decades later. So far the cancer risk seems to be purely theoretical, but this medication does impair the immune system, and obviously an infection will show up more quickly than cancer. 

Edited May 3, 2023 by Unicorn