Vfrac in Men - qualitative study
Research type
Research Study
Full title
Applicability of Vfrac In Men: A qualitative study of an osteoporotic vertebral fracture screening tool for use in older people with back pain
IRAS ID
301023
Contact name
Emma Clark
Contact email
Sponsor organisation
University of Bristol
Clinicaltrials.gov Identifier
42028479, ISRCTN registry
Duration of Study in the UK
1 years, 1 months, 31 days
Research summary
Having a fracture in the spine due to osteoporosis (weak bones that break easily) considerably increases the chances of having another osteoporotic fracture for both men and women and is a marker of osteoporosis. Identifying people with osteoporotic vertebral fractures (OVFs) provides the opportunity to intervene with bone protection therapies, reducing the risk of further fractures by 30–65%. However, an estimated two-thirds of OVFs are undiagnosed. Potential reasons for this include a high prevalence of all-cause back pain in older people and lack of understanding about which clinical features should be used to trigger referral for a diagnostic spinal radiograph.
To address this, we developed the Vfrac clinical tool. The intention of Vfrac is to help healthcare practitioners in primary care decide if an older woman with back pain is at high risk of an OVF and therefore requires a spinal radiograph to confirm the diagnosis.
All development work to date has been carried out in women due to their higher background prevalence of OVF. We now wish to assess Vfrac in men. There is clear evidence that moderate and severe OVFs in men predict future hip fractures in a similar way to women. There is support for the assumption that the underlying biology of osteoporosis and OVFs is similar in men and women. Pharmaceutical studies have shown that bone protection therapies work equally well in men and women in protecting against future OVFs. However, there remain questions around men’s characterisation of back pain symptoms in the context of OVF.
Therefore, the aims of this application are:
1. Understand and further characterise pain symptoms and experiences of men with OVFs
2. Understand men’s views on the content and wording of the questions in the current Vfrac tool
3. Modify the Vfrac decision tool to be more relevant to men if necessary.REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/PR/0088
Date of REC Opinion
11 Feb 2022
REC opinion
Favourable Opinion