Cardiovascular Safety and Fracture Prevention Effectiveness of Denosumab Versus Oral Bisphosphonates in Patients Receiving Dialysis : A Target Trial Emulation
Authors' conclusion
It was estimated that, compared with oral bisphosphonates, denosumab lowered the risk for fractures by 45% and increased the risk for MACE by 36%. The estimates, however, are imprecise and need to be confirmed in future studies.
Study context
- Population
- Dialysis-dependent adults aged ≥50 years initiating denosumab or oral bisphosphonates for osteoporosis; Japanese administrative claims database (April 2014 to October 2022); mean age 74.5 years, 62.9% women
- Participants
- 1,032 adults
- Exposure
- Denosumab vs oral bisphosphonates
- Denosumabn = 658
- Oral bisphosphonatesn = 374reference
- Outcome
- Effectiveness: composite of all fractures; safety: MACE
- Follow-up
- 3 years
Methodological detailstarget trial emulation, administrative claims database, weighted analysis
- Target trial emulation
- Administrative claims database
- Weighted analysis
Main finding
As reported in the abstract
Composite of all fractures (effectiveness outcome)
Weighted 3-year risk difference for composite fractures
−5.3%
CI, −11.3% to −0.6%
Weighted 3-year risk ratio for composite fractures
0.55
CI, 0.28 to 0.93
Observational data: associations, not effects.
Safety
Major adverse cardiac events (MACE) (safety outcome) · 3 years
- Weighted 3-year risk difference for MACE
- 8.2% (95% CI, −0.2% to 16.7%)
- Weighted 3-year risk ratio for MACE
- 1.36 (CI, 0.99 to 1.87)
Original publication
Cardiovascular Safety and Fracture Prevention Effectiveness of Denosumab Versus Oral Bisphosphonates in Patients Receiving Dialysis : A Target Trial Emulation. Ann Intern Med. Published 7 January 2025. doi:10. 7326/ annals-24-03237
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