Prevalence of preexisting articular bone pathology in patients with osteoarthritis screened for fasinumab clinical trials identified by X-ray or magnetic resonance imaging
Authors' conclusion
Approximately one in 20 participants with OA who met the clinical screening criteria for fasinumab phase 3 trials were later excluded due to preexisting severe articular bone pathology findings by X-ray or MRI.
Study context
- Population
- Patients with hip or knee pain due to osteoarthritis (OA) screened for three phase 3 fasinumab studies21,997 proceeded to imaging
- Participants
- 27,633 patients
- Primary endpoint
- Prevalence of preexisting severe articular bone pathology (X-ray or MRI) leading to exclusion
Methodological detailsX-ray and magnetic resonance imaging (MRI) screening
- X-ray and MRI screening
Primary result
As reported in the abstract
Exclusion due to ≥1 joint with severe articular bone pathology (X-ray or MRI), among those imaged
- Excluded for severe articular bone pathology
- 1203 (5.5%)
- Bone fragmentation/collapse
- 2.60%
- Subchondral insufficiency fracture (SIF)
- 1.67%
- Osteonecrosis
- 1.11%
- Significant bone loss
- 0.32%
Further findings
Screen failure due to extensive subchondral cysts
- Extensive subchondral cysts
- 3.13%
Exclusions evident on X-ray
- Bone fragmentation/collapse
- 386/572
- Osteonecrosis
- 141/245
- Significant bone loss
- 59/71
- SIF
- 133/367
- Extensive subchondral cysts
- 229/689
Original publication
Prevalence of preexisting articular bone pathology in patients with osteoarthritis screened for fasinumab clinical trials identified by X-ray or magnetic resonance imaging. Osteoarthritis Cartilage. Published 14 July 2024. doi:10.
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