Denosumab withdrawal increases vertebral fracture and mortality risk compared with zoledronate
Main finding · Vertebral fractures (VFs)Result — go to the resultHazard ratio 1.479 95% CI 1.222–1.789Authors' conclusion
After adjusting for drug discontinuation, Dmab showed an increased risk of VFs within the first 2 years, contributing to an elevated overall mortality risk. Sensitivity analyses revealed consistent results across different regions.
Study context
- Population
- Osteoporosis patients aged 50 years or older, TriNetX US network10,422 matched
- Participants
- 11,104 vs 15,976
- Exposure
- DMAB withdrawal vs zoledronate discontinuation
- Denosumab (Dmab)n = 11,104
- Zoledronate (ZOL)n = 15,976reference
- Outcome
- Vertebral fractures (VFs)
Methodological detailspropensity-score matched, TriNetX US network
- Propensity-score matched
- TriNetX US network
Main finding
As reported in the abstract
Hazard ratio
1.479
95% CI 1.222–1.789
Dmabvs ZOL
HR 1.479 (95% CI 1.222–1.789)
Observational data: associations, not effects.
Further findings
| Outcome | HR (CI) | |
|---|---|---|
| Thoracic VFs | 1.309 (1.023–1.674) | |
| Lumbar VFs | 1.865 (1.425–2.440) | |
| Collapsed VFs | 1.928 (1.462–2.542) | |
| All-cause mortality | 1.588 (1.475–1.710) | |
| 0.20.5125Hazard ratio (log scale) |
VF risk by subgroup
- Increased VF risk with Dmab vs ZOL in female, aged 50-64, ≥65 years and white patients, regardless of fracture history
Original publication
Denosumab withdrawal increases vertebral fracture and mortality risk compared with zoledronate. Eur J Endocrinol. Published 30 January 2025. doi:10. 1093/ ejendo/ lvaf013
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