Study type

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
Non-interventional study

Non-interventional study design

Cohort
Case-control
Other

Non-interventional study design, other

Case-crossover, self-controlled case series, 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

(N05BA) Benzodiazepine derivatives
Benzodiazepine derivatives
(N05CD) Benzodiazepine derivatives
Benzodiazepine derivatives
(N05CF) Benzodiazepine related drugs
Benzodiazepine related drugs
(N05CM) Other hypnotics and sedatives
Other hypnotics and sedatives

Medical condition to be studied

Hip fracture
Femur fracture
Population studied

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 benzodiazepines 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

Descriptive study of use of BZD and incidence/prevalence of hip/femur fractures.Cohort: Incidence rates of hip/femur fractures (IR), Poisson regression analysis will be used to estimate age and gender adjusted Incidence Rate Ratio (IRR) and Time-dependent Cox proportional hazards models.Case-Control: Conditional logistic regression analysis to estimate the odd ratio (OR) and 95% CI of hip/femur fracture associated with the current use of benzodiazepines as compared to past use and adjusting for confounding variables. Case-crossover:Conditional logistic regression. It is analogous to a matched case-control study design, where one compares a ‘case’ person-moment with a series of ‘control’ person-moments from different subjects. Self Control Case Series: IR will be calculated for each risk window and data will be analyzed with conditional Poisson regression adjusted by gender and age to calculate incidence rate ratios