Status: Finalised
First registered on:
12/11/2020
Last updated on:
16/01/2023
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 analysis31/01/202231/01/2022
Date of interim report, if expected
Date of final study report31/07/202221/10/2022
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)
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)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Hip fracture
8. Population under study
Age
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects3000000
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Disease/case registry
Administrative database, e.g. claims database
Routine primary care electronic patient registry
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
To characterize hip fractures by year among men and women aged 50 years and above within multiple countries.
Are there primary outcomes?Yes
To estimate the annual incidences of hip fracture.
Are there secondary outcomes?Yes
• To estimate the proportion of patient having use of a pharmacological treatment for fracture prevention within 12 months following their initial hip fracture by year.
• To estimate the mortality rate within 12 months following patients’ initially hip fracture by year.
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
1 year
15. Data analysis plan
Please provide a brief summary of the analysis method
The primary outcome will be calculated as the sum of hip fracture episodes in the year divided by the population at-risk in the year. A linear regression model will be used to test for time trends in the annual incidence proportion. Two-tailed P<0.05 will be considered statistically significant. For the 1st secondary outcome, the Kaplan-Meier method will be used to estimate the treatment proportion within 3, 6 & 12 months of fracture and 95% confidence intervals (CI), censoring patients on another hip fracture episode, 12 months, death, loss to follow-up, 31st December 2018 or the end of data available in a database; whichever earliest. For the 2nd secondary outcome, rate per calendar year of initial hip fracture will be calculated as the sum of patients who died of any cause during the 12-month follow-up period divided by the sum of patients with an initial hip fracture.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
