The risk of musculoskeletal adverse outcomes after treatment with endocrine blocking treatments for breast cancer (MSKAI)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L02BA01) tamoxifen

  (L02BG06) exemestane

  (L02BG04) letrozole

  (L02BG03) anastrozole

  (L02BG05) vorozole
• Medical condition to be studied:
  Breast cancer female
• Additional medical condition(s):
  Osteoarthritis, Carpal tunnel syndrome, tendinopathy

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:
  500000

Study design details

• Main study objective:
  The aim of this study is to assess the comparative risk of musculoskeletal adverse events in post menopausal women taking of tamoxifen (TMX) versus Aromatase Inhibitors (AI) used in the treatment of breast cancer.
• Outcomes:
  comparative risk of developing carpal tunnel syndrome, osteoarthritis and tendinopathies, If sufficiently powered, this study aims to assess the comparative risk of musculoskeletal adverse events in those taking non-steroidal AIs (NSAIs) versus steroidal AIs (SAIs)
• Data analysis plan:
  New user design within a comparative cohort analysis of tamoxifen versus aromatase inhibitors, with the hazards of outcome during the follow-up periods compared using a univariate Cox proportional hazards model conditioned on the PS adjustment with treatment allocation as the sole explanatory variable