NCT06431867

Brief 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+. 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. 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

May 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

September 16, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

February 4, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

May 22, 2024

Last Update Submit

February 3, 2025

Conditions

Keywords

womenolderprimary-care

Outcome Measures

Primary Outcomes (1)

  • Questionnaire

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

    September 2025

Study Arms (2)

Older women

Women aged 70 years and older with a diagnosis of osteoporosis

Other: Guidelines for primary care management of osteoporosis

Primary healthcare professionals

Any healthcare professional working in a primary care setting e.g. general practitioner, pharmacist, physiotherapist

Other: Guidelines for primary care management of osteoporosis

Interventions

All usual care of osteoporosis in primary care

Older womenPrimary healthcare professionals

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bradford Institute for Health Research

Bradford, West Yorkshire, BD9 6RJ, United Kingdom

RECRUITING

Related Links

MeSH Terms

Conditions

Osteoporosis

Interventions

Guidelines as Topic

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Anne Heaven, MPhil

    Bradford Institute for Health Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Programme Manager

Study Record Dates

First Submitted

May 22, 2024

First Posted

May 29, 2024

Study Start

September 16, 2024

Primary Completion

March 1, 2025

Study Completion

September 1, 2025

Last Updated

February 4, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

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.

Locations