Osteoporosis, bone & mineral

Cardiovascular Safety and Fracture Prevention Effectiveness of Denosumab Versus Oral Bisphosphonates in Patients Receiving Dialysis : A Target Trial Emulation

Ann Intern MedPublished Observational cohort study emulating a target trial

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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