Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology
Other

If ‘other’, further details on the scope of the study

Analysis of discrepancies in results between different databases

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Case-control
Cohort
Other

Non-interventional study design, other

Case-crossover, Descriptive study= description of exposure and/or outcome in the whole database during a defined period of time
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(N06AA) Non-selective monoamine reuptake inhibitors
Non-selective monoamine reuptake inhibitors
(N06AB) Selective serotonin reuptake inhibitors
Selective serotonin reuptake inhibitors

Medical condition to be studied

Hip fracture
Femur fracture
Population studied

Short description of the study population

All patients included in the period of valid data collection. The study period will be defined from January 1, 2001 to December 31, 2009.

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)
Children (2 to < 12 years)
Adolescents (12 to < 18 years)
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

55700000
Study design details

Main study objective

To assess the association between the use of antidepressants and the risk of hip/femur fracture with different study designs across different primary care databases and to compare the results between databases, across designs to evaluate the impact of design/database/population differences on the outcome of the studied association.

Data analysis plan

Retrospective cohort: incidence rates (IR) of hip/femur fractures (outcome) will be calculated in current, recent & past users. Past use will be the reference category. Poisson regression (regr) will be used to estimate age & gender adjusted IRR. Time-dependent Cox proportional hazards models will also be used to calculate HR and 95% CIs. Nested case control:Conditional logistic regr analysis will be used to estimate the risk of the outcome associated with the current use of AD as compared to past use. The risks will be calculated in terms of odds ratios (OR) with corresponding 95% CI. case-crossover For each case, the cumulative exposure will be assessed in the 6 months before the index date (at-risk period). For each case up to 4 control moments will be defined at 6 months intervals starting immediately prior to the at-risk period. Cumulative exposure will also be assessed in these 'control' person moments.Conditional logistic regression analysis will be done