A scoping review of real-world evidence generation methods to estimate the safety of type 2 diabetes medications on fracture risk
Authors' conclusion
We identified large variation in RWE methods used to investigate T2DM medications and fracture risk. Few studies considered biological plausibility or transitions in therapy in their design or provided detail to be able to replicate.
Study context
- Population
- Observational studies in adults using healthcare administrative data to estimate the effect of T2DM medication on fracture risk; MEDLINE, Embase and CINAHL, January 2000–December 2022, English
- Participants
- 50 eligible studies
- Outcome
- Real-world evidence (RWE) methods in included studies
Main finding
As reported in the abstract
- Study designs: cohort
- 40
- Study designs: case-control
- 9
- Study designs: self-controlled case series
- 1
- Cohort studies defining medication exposure with an intention-to-treat approach
- 60%
- Cohort studies considering time trends
- 1
- Studies reporting an exposure-outcome risk window (19 cohort and 1 case-control)
- 40%
- Cohort studies justifying biological plausibility
- 2
- Studies defining how fractures were measured
- 46%
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
A scoping review of real-world evidence generation methods to estimate the safety of type 2 diabetes medications on fracture risk. Osteoporos Int. Published 21 November 2025. doi:10.
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