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Completed

NCT Number: NCT05081466

Diet and Hip Fracture Risk 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.

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Key information

Conditions

Hip Fracture (First Incidence of) Bone Diseases Bone Diseases, Metabolic Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Wounds and Injuries

Age range

36 year–69 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dietary pattern

Other

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

Fruit and vegetable intake

Other

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

Meat intake

Other

Red meat, poultry, processed meat from food frequency questionnaire

Fish intake

Other

Intake of fish from food frequency questionnaire

Egg intake

Other

Intake of eggs from food frequency questionnaire

Dairy intake

Other

Intake of dairy products from food frequency questionnaire

Tea intake

Other

Intake of tea (drink) from food frequency questionnaire

Coffee intake

Other

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

Tea and coffee intake

Other

Combined intake of tea and coffee from food frequency questionnaire

Protein intake

Other

Estimated intake of protein, derived from food frequency questionnaire

Calcium intake

Other

Estimated intake of calcium, derived from food frequency questionnaire

vitamin D intake

Other

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Registry information

Official study title

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

Important dates

Study start
1995
Primary completion
2019
Study completion
2022
First posted
Oct 18, 2021
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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