Study type

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Osteoporosis
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

750000
Study design details

Main study objective

To undertake a comprehensive descriptive analysis of the six proposed subcohorts:• Describing the demographical, clinical characteristics of each subcohort.• Estimate 1-year and 2-year fracture incidence rates and cumulative incidence functions over time in the six defined subcohorts

Outcomes

Incident fracture during the 1 and 2 years follow-up period, per major osteoporotic sites, according to QFracture risk score definition (hip, spine, non-hip non-spine, hip/humerus/wrist). • Fatal fracture (during the 1- and 2-year follow-up period)• Fracture-related hospital admission (during the 1- and 2-year follow-up period)• All-cause mortality (during the 1- and 2-year follow-up period)• Drug exposure (during the 1- and 2-year follow-up period)

Data analysis plan

Each subcohort will be described according to a list of pre-specified variables, contingency tables will be drawn, 1-year fracture incidence rates and cumulative incidence function over time will be estimated for: osteoporotic fracture, fatal fracture, and hospitalization related to fracture. The analyses run in the six pre-defined cohort populations, separately in each datasets (CPRD, DHR, SIDIAP).Performance of the QFracture risk score for imminent fracture (1-year) will be examined in the six pre-defined cohort populations, by estimating the related indicators (see below). Of note, the analyses will be run separately in each dataset (CPRD, DHR, SIDIAP).