Diet and Hip Fracture Risk in the United Kingdom Women's Cohort

September 21, 2022 updated by: Darren Greenwood, University of Leeds

Associations Between Diet and Hip Fracture Incidence in the United Kingdom Women's Cohort

Hip fracture is a common serious injury in older women that reduces quality of life and can lead to premature death. In the United Kingdom, hip fractures are estimated to account for 1.5 million hospital bed days used per year due to long hospitalisation and rehabilitation periods post-surgery, costing the National Health Service over £1 billion per year. Diet can affect bone health and risk of hip fracture, with varying risks in women on specific diets, and specific foods and nutrients playing more important roles than others. Vegetarians may be at a greater risk of hip fracture than meat-eaters, and those who don't consume enough protein could be at a greater risk than those with adequate intakes. This research aims to investigate which dietary factors (and in what quantities) might predispose United Kingdom women to a greater risk of hip fracture, and which factors may be protective. The purpose of this study is to better understand the role of diet in reducing hip fracture risk in United Kingdom women. The research will use existing dietary and lifestyle data from the United Kingdom Women's Cohort Study and hospital records of hip fractures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Hip fracture is an increasingly prevalent global health condition that increases morbidity and mortality. Previous observational studies have shown potential for risk reduction through diet modification, but associations between many dietary factors and hip fracture incidence are uncertain, and evidence in United Kingdom populations is limited. Therefore, this study aims to assess associations between diet and hip fracture incidence in the United Kingdom Women's Cohort.

Research plan and methods: The investigators will utilise dietary and lifestyle data from the United Kingdom Women's Cohort which recruited 35,372 middle-aged women between 1995-1998. This data has been linked with Hospital Episode Statistics to provide hip fracture data of participants.

Cox regression models will be applied to explore potential associations between dietary factors and hip fracture incidence. Dietary factors will be modelled both as categorical and continuous so that models can be fit comparing the risk of hip fracture between categories of intakes and per increment increase in exposure intake (linear dose-response). Cubic splines will be used to model non-linear associations for dietary intake of fruits, vegetables, tea, and coffee since previous research has suggested possible non-linear associations for these variables.

Study Type

Observational

Enrollment (Actual)

35372

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS2 9JT
        • University of Leeds

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The UK Women's cohort profile is published here: [https://doi.org/10.1093/ije/dyv173].

Description

Inclusion Criteria:

  • Female
  • Ages 35 - 69 years at time of recruitment
  • Able to provide informed consent

Exclusion Criteria:

  • Male
  • Not a resident of England
  • Unable to link dietary and lifestyle data with hospital episode data
  • Missing covariate data
  • Hip fracture or osteoporosis prevalence before or on the date of recruitment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
United Kingdom Women's Cohort
United Kingdom Women's Cohort Study. No interventions are to be administered in this observational prospective cohort study.
Other: Dietary pattern
(regular meat-eater, occasional meat-eater, fish-eater, vegetarian, and vegan)
Other: Fruit and vegetable intake
Intake of fruits, vegetables, fruits and vegetables combined from food frequency questionnaire
Other: Meat intake
Red meat, poultry, processed meat from food frequency questionnaire
Other: Fish intake
Intake of fish from food frequency questionnaire
Other: Egg intake
Intake of eggs from food frequency questionnaire
Other: Dairy intake
Intake of dairy products from food frequency questionnaire
Other: Tea intake
Intake of tea (drink) from food frequency questionnaire
Other: Coffee intake
Intake of coffee (caffeinated or decaffeinated) from food frequency questionnaire
Other: Tea and coffee intake
Combined intake of tea and coffee from food frequency questionnaire
Other: Protein intake
Estimated intake of protein, derived from food frequency questionnaire
Other: Calcium intake
Estimated intake of calcium, derived from food frequency questionnaire
Other: Vitamin D intake
Estimated intake of vitamin D, derived from food frequency questionnaire and any recorded supplemental intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hip fracture incidence (first)
Time Frame: age when the completed questionnaire was returned (1995-1998) until age at event, death, or end of study period (19 Mar 2019)
Incidence of first hip fracture ascertained from linkage to Hospital Episode Statistics (HES) data
age when the completed questionnaire was returned (1995-1998) until age at event, death, or end of study period (19 Mar 2019)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leeds

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 1995

Primary Completion (Actual)

March 13, 2019

Study Completion (Actual)

July 31, 2022

Study Registration Dates

First Submitted

October 5, 2021

First Submitted That Met QC Criteria

October 5, 2021

First Posted (Actual)

October 18, 2021

Study Record Updates

Last Update Posted (Actual)

September 23, 2022

Last Update Submitted That Met QC Criteria

September 21, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRA 17/YH/0144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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