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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Emma
Clark
+44 117 414 7862
Vfrac-study@bristol.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Osteoporotic vertebral fractures
This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.
Background and study aims
A vertebral fracture (broken bone in the back due to weak bones) increases the chance of more fractures, but only one in three patients are diagnosed. One reason for this is because medical staff find it difficult to know who should have a spinal X-ray.
To help medical staff decide, we have carried out a study that has resulted in the Vfrac tool. We now want to look at Vfrac in men.
There are three stages to this new study:
1. Interviewing men with vertebral fractures to see if they describe their back pain in a similar way to women, and listening to their views on the content and wording of the questions in Vfrac
2. Updating the Vfrac tool to be relevant to men
3. Testing the updated Vfrac tool to see if it works in men as well as it does in women. If so, men will be included in future research into Vfrac
Who can participant?
Men aged 65+ years with back pain. For stage 1 men must have a vertebral fracture.
What does the study involve?
Stage 1 involves talking to a researcher (an interview) for 60-90 minutes on the telephone, by video call or face-to-face about back pain symptoms and views on the current version of our Vfrac checklist.
Stage 3 involves completing a questionnaire at home and sending your answers back to the research team.
What are the possible benefits and risks of participating?
Talking to us as part of the study will take up a little time, although we will try and keep interviews as short as possible. Participants are also free to take breaks during the interview. We will also try to make any adjustments needed to make it easier to take part.
It may also be distressing to talk about how it feels to break a spinal bone. Participants are free to stop or to decide not to answer any questions without giving a reason, at any time. We will also provide lists of contacts for support and advice.
Although this study will not benefit participants directly, we hope that this study will make it easier to identify men who have broken a bone in their back in the future.
Where is the study run from?
The University of Bristol (UK)
When is the study starting and how long is it expected to run for?
December 2020 to September 2024
Who is funding the study?
Stages 1 and 2 are funded by a research grant from the Royal Osteoporosis Society (Ref 462). Stage 3 is funded by the Southmead Hospital Charity.
Who is the main contact?
The Vfrac study team can be contacted using the email address Vfrac-study@bristol.ac.uk
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
Stage 11. Female2. Aged under 65 years3. Potential participant is not aware they have a vertebral fracture4. Spinal malignancy (cancer) mentioned in the radiology report5. Patients who do not have the capacity to provide informed consent. Capacity to consent will be assessed by the researcher, in consultation with a clinical members of the study team (EC). This is in accordance with the Mental Capacity Act 2005 (https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/mental-capacity-act/).6. Participants who are unwilling to provide informed consent.
Stage 3:1. Female2. Aged under 65 years3. Spinal malignancy (cancer) mentioned in the radiology report4. Patients who do not have the capacity to provide informed consent. Capacity to consent will be assessed by the researcher, in consultation with a clinical members of the study team (EC). This is in accordance with the Mental Capacity Act 2005 (https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/mental-capacity-act/).5. Participants who are unwilling to provide informed consent.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Emma
Clark
+44 117 414 7862
Vfrac-study@bristol.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Bristol and funded by Royal Osteoporosis Society; Southmead Hospital Charity.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
