Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Case-control
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(M05BA) Bisphosphonates
Bisphosphonates
(M05BB) Bisphosphonates, combinations
Bisphosphonates, combinations

Medical condition to be studied

Atypical femur fracture
Population studied

Age groups

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

Estimated number of subjects

380
Study design details

Main study objective

The aim of this study is to evaluate the association between the use of bisphosphonates and the risk of subtrochanteric or diaphyseal fractures among women aged 50 or older.

Outcomes

Evaluate the association between the use of bisphosphonates and the risk of subtrochanteric or diaphyseal fractures among women aged 50 or older, Hospitalization data, demographics data, anthropometrics data, toxic habits data, clinical data, prescribed medication data, complementary examinations data, body mass index, Chalson index, Glomerular filtration rate and osteoporosis grade.

Data analysis plan

OR for atypical femoral fracture risk associated to the use of bisphosphonates will be determined by logistic regression. Age, body mass index, smoking, alcoholism, malabsorption, rheumatoid arthritis, diabetes, thyroid disease and Charlson index and exposure to drugs will be covariates in a logistic regression model.