RRA-17425, Risperidone Exposure and the Risk of Osteoporosis-related Fractures – Sweden

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
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-control

  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  RISPERIDONE
• Medical condition to be studied:
  Hip fracture

Population studied

• Short description of the study population:
  Adult patients with hip fracture with or without exposure to risperidone.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Hip fracture patients
• Estimated number of subjects:
  116347

Study design details

• Main study objective:
  To compare the exposure of risperidone and other atypical antipsychotics in association with hip/femur fracture incidence. To estimate and compare the incidence of hip/femur fractures in users of risperidone, users of other atypical antipsychotics, and users of conventional antipsychotics.
• Outcomes:
  Hip and femur fractures, Non-hip and femur fractures
• Data analysis plan:
  Incidence rates of osteoporosis-related fractures were estimated for each of the threecohorts, according to total cohort follow-up time and active treatment follow-up time,respectively, and reported as number of cases per 100,000 person-years. Hazard ratios(HRs) and 95% confidence intervals (CIs) for osteoporosis-related fractures among those exposed to risperidone compared with those exposed to other atypical antipsychotics or typical antipsychotics were estimated.Odds ratio (OR) and 95% CI for osteoporosis-related fractures was estimated bycomparing exposure to risperidone to exposure to other atypical antipsychotics, amongcases and controls. The exposures were studied retrospectively from the date of diagnosis of an osteoporosis-related fracture in the following time categories: any time, current, recent, and past.