Observational study assessing incidence of osteosarcoma among Forteo(teriparatide) users by linking state cancer registry data to large national pharmacy database data (B3D-MC-GHBX Addendum 2.3)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Observational study
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (H05AA02) teriparatide

  teriparatide
• Medical condition to be studied:
  Osteosarcoma

Population studied

• Short description of the study population:
  Adult patients aged ≥18 years treated with Forteo were compared to an untreated population.
• 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)
• Estimated number of subjects:
  477000

Study design details

• Main study objective:
  To estimate the incidence of osteosarcoma in patients who have received treatment with Forteo over time as compared to a general population comparator cohort using an incidence rate ratio (IRR) and 95% confidence interval (CI).
• Outcomes:
  Incidence of osteosarcoma
• Data analysis plan:
  Incidence rate and IRR for osteosarcoma will be estimated among Forteo users versus matched comparator cohorts. For the primary analysis of each linkage, the IRR and 95% CI for osteosarcoma occurrence in Forteo users and nonusers will be estimated using exact conditional Poisson regression.