Hearing loss and risk of major osteoporotic fracture: a population-based cohort study in the United Kingdom (20200418)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49608
• EU PAS number:
  EUPAS44961
• Study ID:
  49608
• Official title and acronym:
  Hearing loss and risk of major osteoporotic fracture: a population-based cohort study in the United Kingdom (20200418)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The overarching aim is to assess the association between hearing loss/impairment and fracture risk using the Clinical Practice Research Datalink (CPRD) and to generate a new short-term (1-year) as well as long-term (10-year) major osteoporotic fracture risk prediction tool for patients with hearing loss that will help clinicians to identify a population at high-risk of fracture.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Actual: 22/04/2021

Study start date

Planned: 06/05/2022

Actual: 06/05/2022

Data analysis start date

Planned: 01/08/2022

Actual: 01/08/2022

Date of final study report

Planned: 31/03/2023

Actual: 17/10/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Regulatory

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