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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/27245
• EU PAS number:
  EUPAS18547
• Study ID:
  27245
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This cohort study will estimate the incidence rate and IRR for osteosarcoma among adult patients aged ≥18 years treated with Forteo compared to an untreated population. Drug exposure data will be obtained from dispensed pharmacy claims and osteosarcoma diagnosis information will be obtained from state cancer registry files.
• Study status:
  Finalised

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 06/04/2016

Actual: 06/04/2017

Study start date

Planned: 16/01/2017

Actual: 16/01/2017

Data analysis start date

Planned: 03/05/2017

Date of final study report

Planned: 14/09/2017

Actual: 11/10/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

B3D-MC-GHBX Amendment (2.3)(b)

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable