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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/27249
• EU PAS number:
  EUPAS18117
• Study ID:
  27249
• Official title and acronym:
  Assessing the Incidence of Osteosarcoma Among Teriparatide Users Using Medicare Part D and State Cancer Registry Data (B3D-MC-GHBX Addendum 2.2)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This population-based cohort study will utilize secondary data to compare the incidence of osteosarcoma among Forteo users aged 65 years and older with the incidence of osteosarcoma among nonusers aged 65 years and older. Exposure will be ascertained from prescription drug claims, and outcome will be ascertained through linkage with state cancer registries. Forteo users will be matched to nonusers based on demographic and baseline characteristics.
• Study status:
  Finalised

Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Study timelines

Date when funding contract was signed

Planned: 18/08/2014

Actual: 18/08/2014

Study start date

Planned: 06/10/2016

Actual: 06/10/2016

Data analysis start date

Planned: 01/05/2017

Date of final study report

Planned: 14/09/2017

Actual: 25/04/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

GHBX 2_2a

Regulatory

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