Osteoporotic vertebral fracture Musculoskeletal Diseases Osteoporosis
Conditions
Interventions
After GP practice recruitment, participants will be recruited via the GP practice. They will be sent an invitation letter, two copies of the first consent form, the participant information sheet and t
Sponsors
University of Bristol
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Willing and able to give informed consent for participation in the study 2. Self-reported back pain in the previous 4 months 3. Aged over 65 years
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 23/01/2019: 1. Aged 65 years or under 2. No self-reported back pain reported in the previous 4 months 3. Has already had a full spinal x-ray in the previous 4 months that is not available to the research team 4. Considered unsuitable to take part by their GP (e.g. cognitive impairment or near end of life) Previous exclusion criteria: 1. Aged 65 years or under 2. No self-reported back pain reported in the previous 4 months 3. Has already had a full spinal x-ray in the previous 4 months 4. Considered unsuitable to take part by their GP (e.g. cognitive impairment or near end of life)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be the accuracy of the Vfrac tool as estimated by the sensitivity and specificity. We are aiming for a sensitivity and specificity of greater than 80% to justify subsequent exploration in a definitive trial. The method of measurement will be self-reported questionnaire data at recruitment followed by data collection in research clinic plus spinal radiograph as soon as possible after recruitment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cost effectiveness of Vfrac based upon follow-up of women from the primary outcome cohort to identify if a future definitive cluster randomised controlled trial is appropriate 2. Sources of variance that can be tested in a pilot as part of a future bid 3. Stopping rules for a future trial. The output of this will be a decision on whether a future definitive trial is warranted. | — |
Countries
England, United Kingdom
Contacts
Public ContactEmma Clark
Outcome results
None listed