Study type

Study topic

Disease /health condition

Study type

Non-interventional study

Scope of the study

Disease epidemiology

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Retrospective study
Study drug and medical condition

Medical condition to be studied

Hip fracture
Population studied

Short description of the study population

Patients hospitalized with hip fracture aged 50 years and older identified from 1st January 2005 to 31st December 2018.
Inclusion criteria:
o aged 50 years or above
o hospitalized due to hip fracture during the study period between 1st January 2005 and 31st December 2018

Exclusion criteria:
o diagnosis of hip fracture within 12 months before the initial fracture
o missing sex or age
o less than 12 months in the data source before the initial hip fracture

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

Other

Special population of interest, other

Patients with hip fracture

Estimated number of subjects

3000000
Study design details

Main study objective

To characterize hip fractures by year among men and women aged 50 years and above within multiple countries.

Outcomes

To estimate the annual incidences of hip fracture. • To estimate the proportion of patient having use of a pharmacological treatment for fracture prevention within 12 months following their initial hip fracture by year. • To estimate the mortality rate within 12 months following patients’ initially hip fracture by year.

Data analysis plan

The primary outcome will be calculated as the sum of hip fracture episodes in the year divided by the population at-risk in the year. A linear regression model will be used to test for time trends in the annual incidence proportion. Two-tailed P<0.05 will be considered statistically significant. For the 1st secondary outcome, the Kaplan-Meier method will be used to estimate the treatment proportion within 3, 6 & 12 months of fracture and 95% confidence intervals (CI), censoring patients on another hip fracture episode, 12 months, death, loss to follow-up, 31st December 2018 or the end of data available in a database, whichever earliest. For the 2nd secondary outcome, rate per calendar year of initial hip fracture will be calculated as the sum of patients who died of any cause during the 12-month follow-up period divided by the sum of patients with an initial hip fracture.
Documents
Study results
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