The risk of fragility fracture in inflammatory arthritis: evidence for the effective and equitable targeting of prevention

Study type
Protocol
Date of Approval
Study reference ID
15_190
Lay Summary

This study looks at the relationship between inflammatory arthritis (IA), osteoporosis and fragility fracture. IA affects the immune system and causes pain, stiffness and joint damage. The most common forms of IA are rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PSA). Osteoporosis weakens bones, making them fragile and more likely to break. Fragility fractures (fractures that occur from standing height or less) can cause substantial pain, severe disability, reduced quality of life and reduced life expectancy. Studies suggest that patients with RA or AS have an increased risk of osteoporosis and fragility fracture. There is a lack of evidence on PSA and fragility fractures and on the relationship between IA and risk of fracture by age, sex, ethnicity and glucocorticoid use. Glucocorticoid is an anti-inflammatory medicine (commonly called "steroids").

Prevention of fragility fracture is possible but needs to be targeted at those at highest risk. Clearer guidance on who to assess and treat is needed. This study seeks evidence to enable prevention of fragility fractures to be targeted at, and provided with equity to, patients with IA who will benefit most. It examines who is at risk of fragility fractures and who receives pre and post fracture treatment for osteoporosis.

Technical Summary

Objective
To provide evidence to enable prevention of fragility fractures to be targeted at, and provided with equity to, Patients with IA who will benefit most.
Aims
1. Calculate incidence rates of first and subsequent fragility fractures in adults with RA, PSA or AS.
2. Compare absolute risk of first and subsequent fragility fractures in adults with RA, PSA or AS and adults without these conditions.
3. Identify trends over time in fracture incidence.

4. Estimate 5 and 10-year fracture risk in adults with RA, PSA or AS.
5. Identify clinically significant risk factors for first and subsequent fragility fractures in patients with RA, PSA or AS.
6. Identify clinical and socio-demographic predictors of pre and post fracture treatment of patients with RA, PSA or AS with bisphosphonate or denosumab.

Methodology
Retrospective cohort study with matched control using data CPRD of adults 18 years and over with diagnosis of RA, PSA or AS recorded 1987-2014. Patients followed from index date to the first and subsequent fracture.
Data analysis
Cox proportional hazards model to identify risk factors for first and subsequent fractures. Multivariate logistic model of the clinical and socio-demographic predictors of pre and post fracture treatment of patients with RA, PSA or AS with bisphosphonate or denosumab.

Collaborators

Anthony Woolf - Chief Investigator - Royal Cornwall Hospital
Josephine Erwin - Corresponding Applicant - Royal Cornwall Hospital
Doyo Enki - Collaborator - Plymouth University
William Hamilton - Collaborator - University of Exeter

Linkages

Patient Level Index of Multiple Deprivation