Hip Fracture (First Incidence of)NCT05081466
Diet and Hip Fracture Risk in the United Kingdom Women's Cohort
An observational study of Hip Fracture (First Incidence of), run by University of Leeds at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 36 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hip Fracture (First Incidence of)
- What is being tested?
- Dietary pattern, Fruit and vegetable intake and Meat intake
- How many people
- 35,372 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 1995to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The UK Women's cohort profile is published here: [https://doi.org/10.1093/ije/dyv173].
Who may be able to join
- Female
- Ages 35 - 69 years at time of recruitment
- Able to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leeds
Leeds, West Yorkshire, LS2 9JT
About this study
Official title: 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.
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.
- Conditions
- Hip Fracture (First Incidence of)
- Being tested
- Dietary pattern, Fruit and vegetable intake, Meat intake, Fish intake, Egg intake
- Keywords
- Nutrition, Fracture, Cohort study, Epidemiology, Osteoporosis
- Medical subject headings
- Hip Fractures, Fractures, Bone, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary patternOther
(regular meat-eater, occasional meat-eater, fish-eater, vegetarian, and vegan)
Fruit and vegetable intakeOther
Intake of fruits, vegetables, fruits and vegetables combined from food frequency questionnaire
Meat intakeOther
Red meat, poultry, processed meat from food frequency questionnaire
Fish intakeOther
Intake of fish from food frequency questionnaire
Egg intakeOther
Intake of eggs from food frequency questionnaire
Dairy intakeOther
Intake of dairy products from food frequency questionnaire
Tea intakeOther
Intake of tea (drink) from food frequency questionnaire
Coffee intakeOther
Intake of coffee (caffeinated or decaffeinated) from food frequency questionnaire
Tea and coffee intakeOther
Combined intake of tea and coffee from food frequency questionnaire
Protein intakeOther
Estimated intake of protein, derived from food frequency questionnaire
Calcium intakeOther
Estimated intake of calcium, derived from food frequency questionnaire
Vitamin D intakeOther
Estimated intake of vitamin D, derived from food frequency questionnaire and any recorded supplemental intake
| Study group | Role | What they receive |
|---|---|---|
| United Kingdom Women's Cohort | United Kingdom Women's Cohort Study. No interventions are to be administered in this observational prospective cohort study. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip fracture incidence (first)
Incidence of first hip fracture ascertained from linkage to Hospital Episode Statistics (HES) data
Measured: age when the completed questionnaire was returned (1995-1998) until age at event, death, or end of study period (19 Mar 2019)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start15 Jan 1995
- Primary completion13 Mar 2019
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip Fracture (First Incidence of)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35,372 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darren Greenwood, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081466
- Sponsor's protocol ID
- HRA 17/YH/0144
- Status last verified
- Sep 2022
- First submitted
- 5 Oct 2021
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 35948956Webster 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 at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Diet and Hip Fracture Incidence in the United Kingdom Women's Cohort
- ClinicalTrials.gov ID
- NCT05081466
- Acronym / sponsor ID
- HRA 17/YH/0144
- Conditions
- Hip Fracture (First Incidence of)
- Keywords
- Nutrition, Fracture, Cohort study, Epidemiology, Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35,372 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 15 Jan 1995 (actual)
- Primary completion
- 13 Mar 2019 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| United Kingdom Women's Cohort | – | 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 intakeUnited Kingdom Women's Cohort Study. No interventions are to be administered in this observational prospective cohort study. |
Who may qualify
- Ages
- 36 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The UK Women's cohort profile is published here: [https://doi.org/10.1093/ije/dyv173].
Key inclusion criteria (3 listed)
- Female
- Ages 35 - 69 years at time of recruitment
- Able to provide informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary pattern(regular meat-eater, occasional meat-eater, fish-eater, vegetarian, and vegan) | Other | United Kingdom Women's Cohort |
| Fruit and vegetable intakeIntake of fruits, vegetables, fruits and vegetables combined from food frequency questionnaire | Other | United Kingdom Women's Cohort |
| Meat intakeRed meat, poultry, processed meat from food frequency questionnaire | Other | United Kingdom Women's Cohort |
| Fish intakeIntake of fish from food frequency questionnaire | Other | United Kingdom Women's Cohort |
| Egg intakeIntake of eggs from food frequency questionnaire | Other | United Kingdom Women's Cohort |
| Dairy intakeIntake of dairy products from food frequency questionnaire | Other | United Kingdom Women's Cohort |
| Tea intakeIntake of tea (drink) from food frequency questionnaire | Other | United Kingdom Women's Cohort |
| Coffee intakeIntake of coffee (caffeinated or decaffeinated) from food frequency questionnaire | Other | United Kingdom Women's Cohort |
| Tea and coffee intakeCombined intake of tea and coffee from food frequency questionnaire | Other | United Kingdom Women's Cohort |
| Protein intakeEstimated intake of protein, derived from food frequency questionnaire | Other | United Kingdom Women's Cohort |
| Calcium intakeEstimated intake of calcium, derived from food frequency questionnaire | Other | United Kingdom Women's Cohort |
| Vitamin D intakeEstimated intake of vitamin D, derived from food frequency questionnaire and any recorded supplemental intake | Other | United Kingdom Women's Cohort |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Results publication: PubMed 35948956Webster 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.
- Derived from this study: PubMed 36402009Webster 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fracture (First Incidence of), run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05081466, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.