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

Sponsor
University of Leeds (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05081466
Collaborator
(none)
35,372
1
324.5
109

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Dietary pattern
  • Other: Fruit and vegetable intake
  • Other: Meat intake
  • Other: Fish intake
  • Other: Egg intake
  • Other: Dairy intake
  • Other: Tea intake
  • Other: Coffee intake
  • Other: Tea and coffee intake
  • Other: Protein intake
  • Other: Calcium intake
  • Other: Vitamin D intake

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 Design

Study Type:
Observational
Actual Enrollment :
35372 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Associations Between Diet and Hip Fracture Incidence in the United Kingdom Women's Cohort
Actual Study Start Date :
Jan 15, 1995
Actual Primary Completion Date :
Mar 13, 2019
Anticipated Study Completion Date :
Jan 31, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Hip fracture incidence (first) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
36 Years to 69 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Leeds Leeds West Yorkshire United Kingdom LS2 9JT

Sponsors and Collaborators

  • University of Leeds

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Darren Greenwood, Senior Lecturer in Biostatistics, University of Leeds
ClinicalTrials.gov Identifier:
NCT05081466
Other Study ID Numbers:
  • HRA 17/YH/0144
First Posted:
Oct 18, 2021
Last Update Posted:
Oct 18, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Darren Greenwood, Senior Lecturer in Biostatistics, University of Leeds
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 18, 2021