Status: Finalised First registered on: 06/03/2017
Last updated on: 20/12/2018
1. Study identification
EU PAS Register NumberEUPAS18117
Official titleAssessing the Incidence of Osteosarcoma Among Teriparatide Users Using Medicare Part D and State Cancer Registry Data
Study title acronymB3D-MC-GHBX Addendum 2.2
Study typeObservational study
Brief description of the studyThis 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
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/Homepagehttps://www.rtihs.org/services/pharmacoepidemiology-and-risk-management
Details of (Primary) lead investigator
Title Dr
Last name Kellier-Steele
First name Nicole
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed18/08/201418/08/2014
Start date of data collection06/10/201606/10/2016
Start date of data analysis01/05/2017
Date of interim report, if expected
Date of final study report14/09/201725/04/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesEli Lilly and Company100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Kellier-Steele
First name Nicole
Address line 1Lilly Corporate Center
Address line 2 
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
Public Enquiries
Title Dr 
Last name Kellier-Steele 
First name Nicole 
Address line 1Lilly Corporate Center 
Address line 2 
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 
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