Assessing the Incidence of Osteosarcoma Among Teriparatide Users Using Medicare Part D and State Cancer Registry Data (B3D-MC-GHBX Addendum 2.2)

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 data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (H05AA02) teriparatide
• Medical condition to be studied:
  Osteosarcoma

Population studied

• Short description of the study population:
  People enrolled in Medicare Part D. The Forteo (exposed) cohort comprised patients with a health insurance claim for an outpatient medication dispensing of Forteo. These patients wiere individually matched to patients from the general population of Medicare Part D patients with similar demographic and baseline characteristics and with a prescription for a medication other than Forteo (comparator cohort).; ; Patients who meet all of the following inclusion criteria in the order below were included:; 1. Are aged 65 years or older; 2. Have at least 4 months of enrollment prior to first dispensing of Forteo in the exposed cohort (e.g., the index date) or the corresponding index date for the comparator cohort; 3. Had 1 or more prescriptions for Forteo during the study period OR are a member of the Medicare Part D general population
• Age groups:
  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  141000

Study design details

• Main study objective:
  To estimate the incidence rate ratio (IRR) and 95% confidence interval (CI) of osteosarcoma for patients aged 65 years or older with a prescription claim for Forteo versus a cohort of matched comparators.
• Outcomes:
  Osteosarcoma
• Data analysis plan:
  The primary objective of the study is to estimate the IRR and 95% CI of osteosarcoma for patients aged 65 years or older with a prescription claim for Forteo versus a matched comparison cohort with a prescription claim for a drug other than Forteo. The study uses Medicare Part D prescription drug data to identify the cohort of patients aged 65 years or older who have a claim for Forteo and a cohort of nonusers matched to the Forteo users by age, sex, 2- or 3- digit zip code, calendar month of the qualifying prescription, and number of unique therapeutic classes ofmedications dispensed during the prior 4 months. The outcome of osteosarcoma will be ascertained by linkage of the Medicare Part D study files to the data files from state cancer registries.

Documents

Study results

LY333334 B3D-MC-GHBX Non-interventional PASS Final Study Report Addendum 2.2_Redacted