Status: Ongoing First registered on: 12/11/2020
Last updated on: 07/12/2020
1. Study identification
EU PAS Register NumberEUPAS37529
Official titleGlobal burden of hip fractures – trends in incidence, post-fracture treatment, and mortality; a multicountry, observational study (20190532)
Study title acronym
Study typeObservational study
Brief description of the studyThis study aims to characterize hip fractures by year among men and women aged 50 years and above within multiple countries. Patient-level electronic health data will be derived from national or regional databases in 20 countries. Each database is estimated to provide at least several hundred hip fractures per year and up to tens of thousands of hip fractures per year. This study will use a retrospective cohort design, and will include patients who were hospitalized due to hip fracture during the study period. The study period was 14 years, from 1st January 2005 to 31st December 2018. Information will be collected to estimate the annual incidences of hip fractures. The proportion of patients having use of a pharmacological treatment for fracture prevention within 12 months following their initial hip fracture by year and the mortality rate within 12 months following patients’ initial hip fracture by year, will also be estimated.
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 applicableProtocol number 20190532
2. Research centres and Investigator details
Coordinating study entity
Centre nameAmgen
Centre locationUSA
Details of (Primary) lead investigator
Title Dr
Last name Amgen Inc.
First name Global Development Leader
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?N/A
Countries in which this study is being conducted
International study

Australia
Brazil
Canada
China
Denmark
Finland
France
Germany
Hong Kong
Italy
Japan
Korea, Republic of
Netherlands
New Zealand
Singapore
Spain
Taiwan
Thailand
United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed14/08/202014/08/2020
Start date of data collection17/11/202008/10/2020
Start date of data analysis24/11/202001/12/2020
Date of interim report, if expected
Date of final study report15/09/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAmgen100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Amgen Inc.
First name Global Development Leader
Address line 1One Amgen Center Drive
Address line 2 
Address line 3 
CityThousand Oaks, CA 
Postcode91320-1799 
CountryUnited States
Phone number (incl. country code)18054473505 
Alternative phone number 
Fax number (incl. country code) 
Email address medinfo@amgen.com
Public Enquiries
Title Dr 
Last name Amgen Inc. 
First name Global Development Leader 
Address line 1One Amgen Center Drive 
Address line 2 
Address line 3 
CityThousand Oaks, CA 
Postcode91320-1799 
CountryUnited States 
Phone number (incl. country code)18054473505 
Alternative phone number 
Fax number (incl. country code) 
Email address medinfo@amgen.com 
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