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OsteoporosisNCT06431867

Primary Care Management of Osteoporosis in Older Women

An observational study of Osteoporosis, run by Bradford Institute for Health Research at 1 site in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The Investigators aim to improve primary-care for older women with osteoporosis. Older women they spoke with previously felt unseen, unimportant, unheard and uninformed. These women felt that bone/joint health was an important issue for women aged 70+. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Osteoporosis
What is being tested?
Guidelines for primary care management of osteoporosis
How many people
60 participants
Where
1 siteUnited Kingdom
Study dates
16 Sep 2024to Sep 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Thirty women with a diagnosis of osteoporosis aged 70 years and older. The Investigators will purposively sample for maximum variation to ensure inclusion of people from a range of living circumstances, from a mixture of urban and rural locations and spanning the least deprived and most deprived locations (identified from Index of Multiple Deprivation (IMD) deciles based on postcode areas). Interview findings will be reviewed on a regular basis during the co-production workshops and adjusted as necessary to follow emergent leads. Thirty healthcare professionals using a purposive sample based on gender, number of years qualified and IMD score of practice catchment.

Who may be able to join

  • Older women:
  • Osteoporosis diagnosis - either self-reported following a clinical diagnosis or taken from the patient's medical record in the case of the Community Ageing Research 75+ (CARE75+) cohort and Fracture Liaison Service (FLS) patients.
  • Aged 70 years or older to align with the recommendation from our preliminary engagement work.
  • Community dwelling.
  • Healthcare professionals:
  • Working in the National Health Service (NHS) in England to align with the participant sample.

Who cannot join

  • Older women:
  • Aged under 70 years.
  • Lacks capacity to consent to participate in research.
  • Resident in a care home - care home residents are likely to need different types of interventions than community dwelling older women as there are organisational considerations.
  • Member of the co-production workshop.
  • Healthcare professionals:
  • Not performing any NHS work.
  • < 12 months in NHS practice.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Kingdom1 site, 1 recruiting
  • Bradford Institute for Health Research

    Bradford, West Yorkshire, BD9 6RJ

    Anne Heaven, MPhil, 1274 382815, anne.heaven@bthft.nhs.uk

    Nicola Kime, Phd, nicola.kime@bthft.nhs.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: A Qualitative Exploration of Older Women and Primary Healthcare Professional Experiences to Guide Improvements in Osteoporosis Care

The Investigators aim to improve primary-care for older women with osteoporosis.

Older women they spoke with previously felt unseen, unimportant, unheard and uninformed. These women felt that bone/joint health was an important issue for women aged 70+. Osteoporosis is a disease that makes bones more breakable and can lead to significant pain, disability and death, costing approximately £4.4 billion a year in the United Kingdom.

Read more

Women are four times more likely to have osteoporosis than men and suffer fractures earlier. Osteoporosis care is poor in primary care even though good guidelines are available.

The Investigators will work with older women and healthcare professionals to help guide the research. They have already looked at published research and will build on this. They will identify what is important for both older women and professionals to inform the first interview questions. The Investigators will ask older women and healthcare professionals about the diagnosis and treatment of osteoporosis. They will also ask them how they manage osteoporosis as a patient or care provider.

At regular intervals, the Investigators will look at the interview findings first and then share their thoughts with older women and professionals. Together they will explore what the interviews mean. These discussions may change the questions asked and who is interviewed next.

The Investigators will combine all the information from interviews to identify what works well and less well in osteoporosis care. They will check these findings against the guidelines. They will continue to work with older women and healthcare professionals to develop recommendations for improving care. The Investigators will also identify areas of further work.

They will share recommendations with healthcare commissioners and produce a summary for a variety of professional networks. They will also publish papers in journals aimed at healthcare professionals and produce a summary document and advice for older women to use.

Read the detailed description

RESEARCH QUESTION How can older women and primary healthcare professionals be empowered to improve osteoporosis care?

BACKGROUND The Women's Health Strategy for England highlights the lack of focus on older women's needs and experiences. The Investigators talked to 32 older women across five public engagement workshops. These women felt unseen, unimportant, unheard and uninformed. They also felt bone/joint health and osteoporosis were important issues for older women (aged 70+). Osteoporosis leads to around 180,000 fractures per year causing significant pain, disability and death. The related cost, in the United Kingdom, is estimated at £4.4 billion a year. Women are four times more likely to suffer with osteoporosis than men and tend to suffer fractures earlier. Despite comprehensive guidelines being available, evidence suggests that osteoporosis care is lacking in primary care.

AIMS AND OBJECTIVES To develop strategies to improve osteoporosis care using insights from the experience of primary healthcare professionals and older women.

METHODS Ethnographic meta-analysis literature review, in-depth interviews and co-production workshops. An information specialist will update the preliminary literature review. The Investigators will synthesise evidence from older women and healthcare professionals to identify new theoretical constructs. Findings will be reviewed in co-production workshops and used to focus initial lines of enquiry. The Investigators will purposively sample 30 older women, from across England, aged 70+ to interview. They will also elicit the views of healthcare professionals in primary care. Interviews will explore the process of diagnosis, treatment and management of osteoporosis. Information from interviews will initially be reviewed by the Investigators.

Following a Constructivist Grounded Theory approach, the Investigators will take initial findings to co-production workshops on a regular basis throughout fieldwork. Workshops will facilitate iterative analysis and identify theoretical sampling gaps. This process may change the types of questions asked or who is interviewed. The Investigators will combine information from all interviews to identify barriers and facilitators for older women's osteoporosis care, and cross-reference this with existing guidelines. Professional 'expert witnesses' will join the workshops when required. Finally, recommendations for improving osteoporosis care will be co-produced . Areas of further work that would improve osteoporosis care in the future will also be identified.

PATIENT AND PUBLIC INVOLVEMENT Lay members will be involved in co-production workshops throughout the research. The Investigators will also work with an expert patient co-applicant in overall management of the project.

TIMELINES FOR DELIVERY Following 3 months of pre-award set-up, the Investigators will conduct the literature review and develop the interview schedule in months 1-3. Interviews and workshops will happen in months 4-11. A final analysis and report will be available in month 18.

IMPACT AND DISSEMINATION Findings will be sent to Integrated Care Boards responsible for local commissioning to facilitate 'better fit' services. The Investigators will also produce dissemination products for wide distribution through a variety of professional networks. Academic papers will be published in journals targeted at healthcare professionals. Summary information and advice, for older women, will be disseminated via national and community networks and presentations nationwide. These outputs will be aimed at supporting successful implementation of the All Party Parliamentary Group recommendations for better diagnosis, treatment and management.

Conditions
Osteoporosis
Being tested
Guidelines for primary care management of osteoporosis
Keywords
women, older, primary-care
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guidelines for primary care management of osteoporosisOther

    All usual care of osteoporosis in primary care

Study groups in NCT06431867
Study groupRoleWhat they receive
Older womenWomen aged 70 years and older with a diagnosis of osteoporosis
Receives: Other: Guidelines for primary care management of osteoporosis
Primary healthcare professionalsAny healthcare professional working in a primary care setting e.g. general practitioner, pharmacist, physiotherapist
Receives: Other: Guidelines for primary care management of osteoporosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Questionnaire

    Constructivist grounded theory about how osteoporosis in older women is treated and managed in primary care

    Measured: September 2025

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2024
  2. Study start16 Sep 2024
  3. Primary completionMar 2025 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06431867
Sponsor's protocol ID
BTHFT2918
Other IDs
NIHR205378
Status last verified
Feb 2025
First submitted
22 May 2024
Last updated
4 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All external data requests will be reviewed by the Project Management Group. Permission to access anonymised data will be subject to a data sharing agreement. Participants will be asked to explicitly consent to secondary data analysis - this will be optional.

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoporosis, run by Bradford Institute for Health Research 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 4 Feb 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anne Heaven, MPhil (+44 1274382815, anne.heaven@bthft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Questionnaire (time frame: September 2025). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 4 Feb 2025.

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