Study type

Study topic

DiseaseĀ /health condition

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Osteoporotic fracture
Deafness
Population studied

Short description of the study population

The study population included patients aged 60 years or older diagnosed with hearing loss registered in the CPRD database from January 1, 2001 to December 31, 2020.

Age groups

Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Frail population
Other

Special population of interest, other

Patients with hearing loss

Estimated number of subjects

200
Study design details

Main study objective

Our overarching aim is to assess the association between hearing loss/impairment and fracture risk, and to generate a new short-term (1-year) as well as long-term (10-year) major fracture risk prediction tool for patients with hearing loss that will help clinicians to identify population at high-risk of fracture.

Outcomes

Major osteoporotic fracture: clinical spine, wrist/forearm, shoulder/proximal humerus, and hip fracture, Performance (calibration and discrimination) of major osteoporotic fracture (clinical spine, wrist/forearm, shoulder/proximal humerus or hip fracture) prediction tools for 1- and 10-years

Data analysis plan

Association analysis between hearing loss/impairment and fracture risk: absolute (incidence rate) and relative risk (proportional hazard Cox models) estimates of overall major fractures and of each major fracture subtype associated with hearing loss (hearing loss patients compared to matched unexposed subjects), stratified by age, sex, and high risk of fracture (prior history of fractures, OP diagnosis and/or anti-OP treatment). Risk factors with statistically significant interactions will be evaluated in sub-group analyses. Identification of the risk factors associated with 1- and 10-year major osteoporotic fracture risk amongst patients with hearing loss/impairment, and the consequent model development.
Documents
Study results
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