Forteo/Forsteo post-approval osteosarcoma surveillance study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20579
• EU PAS number:
  EUPAS8540
• Study ID:
  20579
• Official title and acronym:
  Forteo/Forsteo post-approval osteosarcoma surveillance study
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  Iceland

  Norway

  Sweden
• Study description:
  Teriparatide caused dose-dependent increases in the incidence of osteosarcoma in rats during preclinical testing. Studies have shown that the rat skeleton is more sensitive to the pharmacological effects of parathyroid hormone in formation of new bone and osteosarcomathan monkey or human skeletons. Study GHBX has three components: case-finding surveillance in Europe and the United States and a Forteo Patient Registry in the United States. The case-finding surveillance components were designed to identify documented cases of osteosarcoma among men and women aged 40 years and older and determine which cases, if any, had a history of teriparatide treatment. This report contains results of the European case-finding surveillancecomponent.
• 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

Actual: 30/07/2003

Study start date

Actual: 01/01/2004

Data analysis start date

Actual: 01/01/2004

Date of final study report

Actual: 30/06/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly & Company

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)