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CompletedNCT05081466Updated Sep 23, 2022

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

An observational study in Hip Fracture (First Incidence of), sponsored by University of Leeds. Completed at 1 site in United Kingdom. Open to female participants aged 36 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-23.

Sponsored by University of Leeds · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
35,372
Ages
36 Years to 69 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Hip Fracture (First Incidence of)

Keywords

  • Nutrition
  • Fracture
  • Cohort study
  • Epidemiology
  • Osteoporosis
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 35,372 is above the median of 100 across 675 observational studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

University of Leeds is the lead sponsor of 200 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
36 Years to 69 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
35,372 participants (actual)
Patient registry
No

Groups and cohorts

  • 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 · 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

Interventions

  • OtherDietary pattern

    (regular meat-eater, occasional meat-eater, fish-eater, vegetarian, and vegan)

  • OtherFruit and vegetable intake

    Intake of fruits, vegetables, fruits and vegetables combined from food frequency questionnaire

  • OtherMeat intake

    Red meat, poultry, processed meat from food frequency questionnaire

  • OtherFish intake

    Intake of fish from food frequency questionnaire

  • OtherEgg intake

    Intake of eggs from food frequency questionnaire

  • OtherDairy intake

    Intake of dairy products from food frequency questionnaire

  • OtherTea intake

    Intake of tea (drink) from food frequency questionnaire

  • OtherCoffee intake

    Intake of coffee (caffeinated or decaffeinated) from food frequency questionnaire

  • OtherTea and coffee intake

    Combined intake of tea and coffee from food frequency questionnaire

  • OtherProtein intake

    Estimated intake of protein, derived from food frequency questionnaire

  • OtherCalcium intake

    Estimated intake of calcium, derived from food frequency questionnaire

  • OtherVitamin D intake

    Estimated intake of vitamin D, derived from food frequency questionnaire and any recorded supplemental intake

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What researchers measure

Primary outcomes

  1. Hip fracture incidence (first)

    Incidence of first hip fracture ascertained from linkage to Hospital Episode Statistics (HES) data

    Time frame: age when the completed questionnaire was returned (1995-1998) until age at event, death, or end of study period (19 Mar 2019)

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Study locations

1 site
  • University of Leeds
    Leeds, West Yorkshire LS2 9JT, United Kingdom
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References and documents

Publications

  • Webster J, Greenwood DC, Cade JE. Risk of hip fracture in meat-eaters, pescatarians, and vegetarians: results from the UK Women's Cohort Study. BMC Med. 2022 Aug 11;20(1):275. doi: 10.1186/s12916-022-02468-0. PubMed 35948956 ↗
  • Webster J, Greenwood DC, Cade JE. Foods, nutrients and hip fracture risk: A prospective study of middle-aged women. Clin Nutr. 2022 Dec;41(12):2825-2832. doi: 10.1016/j.clnu.2022.11.008. Epub 2022 Nov 9. PubMed 36402009 ↗

Study documents

  • Statistical analysis plan · Oct 4, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05081466
Lead sponsor
University of Leeds
Responsible party
Darren Greenwood (Senior Lecturer in Biostatistics, University of Leeds) — Principal investigator
First posted
Oct 18, 2021
Start date
Jan 15, 1995
Primary completion
Mar 13, 2019
Completion
Jul 31, 2022
Last update
Sep 23, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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