European Program of Post-Authorization Safety Studies for Protelos®/Osseor® through EU-ADR Alliance

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

  Drug utilisation

  Safety study (incl. comparative)
• 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:
  STRONTIUM RANELATE
• Anatomical Therapeutic Chemical (ATC) code:
  (M05BX03) strontium ranelate

  strontium ranelate
• Medical condition to be studied:
  Osteoporosis

Population studied

• Short description of the study population:
  All osteoporosis patients that are registered for at least one year with one of the participating databases during the study period who are strontium ranelate users and new oral bisphosphonates users (BP).
• 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:
  Osteoporosis patients
• Estimated number of subjects:
  100000

Study design details

• Main study objective:
  Effectiveness of RMM:Characterize utilization patterns of SREstimate the prevalence of CI in SR users Calculate the prevalence of SR users who fulfill the new indicationsSafety:Estimate incidence rates of cardiac and thromboembolic events in SR users with and without CICompare the risk of cardiac and thromboembolic events between new users of SR and of oral bisphosphonates without CI
• Outcomes:
  Contraindications, new indication/prescribing conditions and safety endpoints
• Data analysis plan:
  Effectiveness of RMM:-Incidence/prevalence of SR use, characteristics of users and patterns of use, with stratification by period (before/after implementation of RMM), age and sex.-Prevalence of CI and new indication/restrictions of use, by period, age and sex. Interrupted time series analyses will be used to assess the impact of RMM on these criteria.Safety:-Crude, as well as age and sex-specific incidence rates of the safety endpoints will be estimated separately in new users of SR and bisphosphonates (BP), stratified by period and history of CI.-Conditional logistic regression will be used in nested case-control analyses to compare the risk of the safety endpoints between current use of SR and past use and current use of BP, in persons without CI. Analyses will be stratified by period.All estimates will be calculated by databases and pooled according to a meta-analysis approach. A mega-pooled analysis will estimate the effects putting all individual data together.

Documents

Study results

Abstracts - Final Reports