Global burden of hip fractures – trends in incidence, post-fracture treatment, and mortality; a multicountry, observational study (20190532)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50582
• EU PAS number:
  EUPAS37529
• Study ID:
  50582
• Official title and acronym:
  Global burden of hip fractures – trends in incidence, post-fracture treatment, and mortality; a multicountry, observational study (20190532)
• DARWIN EU® study:
  No
• Study countries:
  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
• Study description:
  This 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 14/08/2020

Actual: 14/08/2020

Study start date

Planned: 17/11/2020

Actual: 08/10/2020

Data analysis start date

Planned: 31/01/2022

Actual: 31/01/2022

Date of final study report

Planned: 31/07/2022

Actual: 21/10/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

EUPAS37529-38037

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

Protocol number 20190532