NCT05081466

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35,372

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1995

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 1995

Completed
24.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2019

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

24.2 years

First QC Date

October 5, 2021

Last Update Submit

September 21, 2022

Conditions

Keywords

NutritionFractureCohort studyEpidemiologyOsteoporosis

Outcome Measures

Primary Outcomes (1)

  • Hip fracture incidence (first)

    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)

Study Arms (1)

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 patternOther: Fruit and vegetable intakeOther: Meat intakeOther: Fish intakeOther: Egg intakeOther: Dairy intakeOther: Tea intakeOther: Coffee intakeOther: Tea and coffee intakeOther: Protein intakeOther: Calcium intakeOther: Vitamin D intake

Interventions

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

United Kingdom Women's Cohort

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

United Kingdom Women's Cohort

Red meat, poultry, processed meat from food frequency questionnaire

United Kingdom Women's Cohort

Intake of fish from food frequency questionnaire

United Kingdom Women's Cohort

Intake of eggs from food frequency questionnaire

United Kingdom Women's Cohort

Intake of dairy products from food frequency questionnaire

United Kingdom Women's Cohort

Intake of tea (drink) from food frequency questionnaire

United Kingdom Women's Cohort

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

United Kingdom Women's Cohort

Combined intake of tea and coffee from food frequency questionnaire

United Kingdom Women's Cohort

Estimated intake of protein, derived from food frequency questionnaire

United Kingdom Women's Cohort

Estimated intake of calcium, derived from food frequency questionnaire

United Kingdom Women's Cohort

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

United Kingdom Women's Cohort

Eligibility Criteria

Age36 Years - 69 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Hip FracturesFractures, BoneOsteoporosis

Interventions

Dietary PatternsFruitTea

Condition Hierarchy (Ancestors)

Femoral FracturesWounds and InjuriesHip InjuriesLeg InjuriesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaFeeding BehaviorFoodFood and BeveragesPlant PreparationsBiological ProductsComplex MixturesBeverages

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer in Biostatistics

Study Record Dates

First Submitted

October 5, 2021

First Posted

October 18, 2021

Study Start

January 15, 1995

Primary Completion

March 13, 2019

Study Completion

July 31, 2022

Last Updated

September 23, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations