Comparative effectiveness and safety outcomes between denosumab and bisphosphonate in South Korea
Main finding · Total fractureResult — go to the resultHazard ratio 1.06 95% CI 0.98–1.15Authors' conclusion
In real-world data reflecting clinical practice, denosumab and bisphosphonate showed comparable effectiveness for total fractures and major osteoporosis fractures, as well as safety regarding acute kidney injury, chronic kidney disease, and atypical femoral fracture.
Study context
- Population
- Subjects over 50 yr taking denosumab or bisphosphonate, January 2018 to April 2022, Health Insurance Review and Assessment Service database (20% sample of Korean population), South Koreapropensity score matched
- Participants
- 91,460 participants
- Exposure
- Denosumab vs bisphosphonate
- Outcome
- Treatment effectiveness (total, major osteoporotic, femur, pelvic and vertebral fracture) and adverse drug reactions (acute kidney injury, CKD, atypical femoral fracture)
Methodological detailsnationwide claims database, 1:1 propensity score matching
- Nationwide claims database
- 1:1 propensity score matching
Main finding
Total fracture
Hazard ratio
1.06
95% CI 0.98–1.15
P = 0.14
Denosumabvs Bisphosphonate
HR 1.06 (95% CI 0.98–1.15); P = 0.14
As reported in the abstract
Observational data: associations, not effects.
Further findings
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| Major osteoporotic fractureComparable | 1.13 (0.97–1.32) | P = 0.12 | |
| 0.512Hazard ratio (log scale) |
Safety
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| Acute kidney injury, age <70 yr subgroupSignificantly lower risk with denosumab · subgroup analysis by age | 0.53 (0.29–0.93) | P = 0.03 | |
| 0.20.5125Hazard ratio (log scale) |
Acute kidney injury, CKD and atypical femoral fracture
- No differences between the 2 groups
Original publication
Comparative effectiveness and safety outcomes between denosumab and bisphosphonate in South Korea. J Bone Miner Res. Published 9 May 2024. doi:10.
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