Osteoporosis & bone health

Efficacy Versus Effectiveness: The HORIZON‐Pivotal Fracture Trial and Its Emulation in Claims Data

Arthritis RheumatolPublished Target trial emulation (nonrandomised database study) of the HORIZON-PFT randomised trial

Primary result · Hip fracture riskResult — go to the resultHazard ratio 0.72 95% CI 0.51–0.92

Authors' conclusion

Real-world emulation of the HORIZON-PFT found that zoledronic acid reduced hip fractures risk over an 18-month follow-up period.

Study context

Population
Women with osteoporosis meeting HORIZON-PFT eligibility criteria, two US claims databases, August 2007 to December 2020 or June 2021
Comparison
Zoledronic acid vs raloxifene
Primary endpoint
Hip fracture
Follow-up
18 months
Methodological detailsUS claims databases, active comparator (raloxifene as proxy for placebo), prespecified agreement metrics, protocol registered before inferential analyses, on-treatment follow-up truncated at 18 months, Original HORIZON-PFT: HR 0.59 (95% CI 0.42-0.83) for hip fracture over 3 years
  • US claims databases
  • Active comparator (raloxifene as proxy for placebo)
  • Prespecified agreement metrics
  • Protocol registered before inferential analyses
  • On-treatment follow-up truncated at 18 months
  • Original HORIZON-PFT: HR 0.59 (95% CI 0.42-0.83) for hip fracture over 3 years

Primary result

Hip fracture risk

Hazard ratio

0.72

95% CI 0.51–0.92

Zoledronic acidvs Raloxifene
HR 0.72 (95% CI 0.51–0.92)

As reported in the abstract

Further findings

OutcomeHR
Interpolated HORIZON-PFT effect on hip fracture at 18 months (HR RCT)Zoledronic acid vs Placebo · interpolated estimate; nearly identical to database HR 0.720.74

Hip fracture risk after 18 months, trial vs database

Trial
9.3 in 1,000
Database analysis
8.3 in 1,000

Original publication

Efficacy Versus Effectiveness: The HORIZON‐Pivotal Fracture Trial and Its Emulation in Claims Data. Arthritis Rheumatol. Published 18 September 2024. doi:10.1002/art.42968

Composed by AI from the published abstract and checked against it. How Briefs are made →

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