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Status: Finalised First registered on: 04/02/2015

Last updated on: 15/08/2017

1. Study identification

EU PAS Register NumberEUPAS8540

Official titleForteo/Forsteo post-approval osteosarcoma surveillance study

Study title acronym

Study typeObservational study

Brief description of the studyTeriparatide 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 osteosarcoma than 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 surveillance component.

Was this study requested by a regulator?Yes: United States

Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)

Regulatory procedure number (RMP Category 1 and 2 studies only)

Other study registration identification numbers and URLs as applicable

2. Research centres and Investigator details

Coordinating study entity

Centre to which the investigator belongsRTI-HS

Department/Research groupPharmacoepidemiology & Risk Management

Organisation/affiliationRTI Health Solutions

Website/Homepagewww.rtihs.org

Details of (Primary) lead investigator

Title Dr

Last name Andrews

First name Elizabeth

Is this study being carried out with the collaboration of a research network?

Other centres where this study is being conducted

Not applicable (single centre)

Countries in which this study is being conducted

International study

Denmark

Finland

Iceland

Norway

Sweden

3. Study timelines: initial administrative steps, progress reports and final report

PlannedActual

Date when funding contract was signed30/07/2003

Start date of data collection01/01/2004

Start date of data analysis01/01/2004

Date of interim report, if expected

Date of final study report30/06/2014

4. Sources of funding

Please provide estimates of the percentage of funding by source for this study

Names(s)Approximate % funding

Pharmaceutical companiesEli Lilly & Company100

Charities

Government body

Research councils

EU funding scheme

5. Contact details for enquiries

Scientific Enquiries

Title Dr

Last name Kellier

First name Nicole

Address line 1Lilly Corporate Center

Address line 2Eli Lilly and Company

Address line 3

CityIndianapolis

Postcode46285

CountryUnited States

Phone number (incl. country code)13172763621

Alternative phone number

Fax number (incl. country code)13174335372

Email address nkellier@lilly.com

Public Enquiries

Title Dr

Last name Kellier

First name Nicole

Address line 1Lilly Corporate Center

Address line 2Eli Lilly and Company

Address line 3

CityIndianapolis

Postcode46285

CountryUnited States

Phone number (incl. country code)13172763631

Alternative phone number

Fax number (incl. country code)13174335372

Email address nkellier@lilly.com

11. Scope of the study

What is the scope of the study?

Case-finding surveillance study

Primary scope : Case-finding surveillance study

12. Main objective(s)

What is the main objective of the study?

The primary objective was to identify newly diagnosed cases of osteosarcoma among men and women aged 40 years or older in selected countries and identify incident osteosarcoma cases with a history of teriparatide treatment. The secondary objective was to collect additional patient information and data related to other risk factors for osteosarcoma.

Are there primary outcomes?Yes

Osteosarcoma

Are there secondary outcomes?No

13. Study design

What is the design of the study?

Case-finding surveillance study

14. Follow-up of patients

Will patients be followed up?Not applicable/no follow-up

15. Data analysis plan

Please provide a brief summary of the analysis method

The analysis compared the observed number of patients with osteosarcoma(OS) with a possible or confirmed exposure to teriparatide to the number of exposed OS cases expected to be identified by cancer registries. The number of patients treated with teriparatide expected to be diagnosed with OS was calculated using the estimated size of the exposed population and background rate for OS in the Nordic countries (i.e., assuming no association between drug exposure and disease). The incidence rate for OS was generated from population estimates for each country, as well as published population-based OS incidence. Population estimates for adults aged 40+ yrs were based on national statistics data for each country. Because this population grew from approximately 12 million in 2004 to 13.24 million in 2013, the population at the approximate midpoint of the study (2008), 12.6 million people aged 40+ yrs, was used for relevant estimates.