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Denosumab and Mortality in a Real-World Setting: A Comparative Study.
Dunia Alarkawi1, Thach Tran1, Weiwen Chen1,2
1Skeletal Diseases Program, Garvan Institute of Medical Research, University of New South Wales, Sydney, Australia.
Summary
Denosumab (Dmab) reduced mortality in women after fracture but increased it in men and women without fracture compared to bisphosphonates (BPs). Oral BPs consistently lowered mortality in fracture patients.
Area of Science:
- Bone Metabolism and Osteoporosis Research
- Pharmacovigilance and Drug Safety
- Epidemiology and Public Health
Background:
- Denosumab (Dmab) is a widely used osteoporosis treatment, but its impact on all-cause mortality, especially compared to bisphosphonates (BPs), requires further investigation.
- Existing research on Dmab's mortality effects is limited, particularly in diverse populations and fracture contexts.
Purpose of the Study:
- To investigate the association between Dmab use and all-cause mortality in individuals with fractures compared to no treatment.
- To examine the association between Dmab use and all-cause mortality in individuals without fractures compared to BPs (oral BPs and zoledronic acid).
Main Methods:
- A new-user cohort design utilizing propensity-score matching was applied to data from the prospective, population-based 45 and Up Study (n=267,357).
- Data linkage included hospital admissions, pharmaceutical records, and secure research environment access.
- Sex-specific multivariable Cox models were used to assess mortality risk in matched cohorts.
Main Results:
- In the fracture cohort, Dmab was associated with significantly lower mortality in women (HR=0.52) but not men, while oral BPs reduced mortality in both sexes (HR=0.56).
- In the no-fracture cohort, Dmab was linked to 1.5- to 2.5-fold higher mortality compared to oral BPs, but showed similar mortality to zoledronic acid.
- Dmab use in women and oral BP use were associated with reduced post-fracture mortality.
Conclusions:
- Denosumab demonstrates a mortality benefit in women following a fracture, similar to oral bisphosphonates.
- In individuals without fractures, Dmab use is associated with increased all-cause mortality compared to oral bisphosphonates, warranting careful consideration of risk-benefit profiles.
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