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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.

Contact Information:

Dr Kenneth Poole


Mrs Karen Willoughby
+44 (0)1223 217580
kw369@medschl.cam.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - PHOENIX-Feasibility: picking up hidden osteoporosis effectively during normal CT imaging without additional x-rays

PHOENIX-Feasibility: picking up hidden osteoporosis effectively during normal CT imaging without additional x-rays

Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Osteoporosis


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.


Osteoporosis is a condition that weakens bones, making them fragile and more likely to break. It is a condition that develops slowly over several years and is often only diagnosed when a minor fall or sudden impact causes a bone break (or fracture). Osteoporosis particularly affects the spine and hips, resulting in breaks of the bone in these areas. Whilst treatment of osteoporosis is now quite straightforward, detection is difficult. In the UK, osteoporosis causes 200,000 fractures of the spine yearly in women and men. The pain of a small spine fracture can feel like ordinary backache, and as a result patients are often left undiagnosed, so many small fractures are common. This eventually leads to poorer mobility and increased pain for the sufferer. The aim of this study is to find out whether it is possible to identify osteoporosis earlier, leading to improved treatment and better outcomes. To do this the researchers will be looking at special scans called CT scans (computerised tomography) that patients are already having for various reasons, and using some new software that has been developed to make more accurate diagnosis of osteoporosis and bone fractures. A CT scan uses x-rays and a computer to create images of the inside of the body; two million are performed each year in the UK, often for abdominal or pelvic problems. In this study, CT images are reviewed using a new software to identify osteoporosis enabling early treatment and potentially preventing future fractures. This new technology makes it simple to measure a patient’s bone density quickly and identify vertebral fractures from CT images of a patient's torso or pelvis. Bone density measurements of the spine and hips are performed on images acquired from any CT scanner. This study is a feasibility study to see if it is realistic to develop into a national trial, so the researchers will be looking at how well they can recruit participants to the study, and as they hope to follow up with a questionnaire after one year, they will also be looking at how many people stay in the study, or drop out.

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:

29 Oct 2019 30 Nov 2024

Publications

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35613783/ (added 27/05/2022)

If someone is attending a CT Department for a scan in a participating hospital and is eligible to be part of the study (that is, within the correct age range and having a scan that includes the pelvis), they will be approached by a member of the research team at the local hospital and asked if they would like to be part of the study. If they are interested in being part of the study the patient will be asked to complete a Bone Health Questionnaire and sign a consent form. The patient will also be asked for their contact details so that the researchers can post out a questionnaire in about 2 months’ time, and later at about 1 year. The answers of the Bone Health Questionnaire will be used to calculate the chance of that patient breaking a bone during the next 10 years. If the answers suggest an increased risk, they will be randomly allocated to one of four study groups. In all four groups, bone density is measured and the scans are studied for evidence of small fractures; in some cases this will happen immediately and in others in 12 months’ time (there will not be a difference in long-term outcomes for the patient if they are in the group with delayed review of the scan). The groups will be chosen at random (like tossing a coin to make a decision) and NOT by the doctor. If answers suggest that the chances of breaking a bone are low, there will be no need to check bone health straight away. Once the CT scans are looked at by the specialist team in Cambridge, a report will be sent to GPs with results and guidance as to any treatment. Two questionnaires are sent out to participants – one after about 2 months, and one at one year. These will ask about any medication that may be prescribed for bone health and how participants are managing in their day to day life; they should take about 15 minutes to complete. A small number of patients will be asked if they would agree to telling us about their experience of the study; this can be by face to face discussion, or over the phone.


Women aged 65 - 90 and men aged 75 - 90 years who are undergoing a CT scan that includes the pelvis

You can take part if:



You may not be able to take part if:


1. Aged > 902. Bilateral metalwork in hips3. Unable to provide valid consent4. Known to be receiving prescription treatment for osteoporosis other than calcium/vitamin D (i.e. bisphosphonate drug, strontium ranelate, denosumab, raloxifene or teriparatide)5. Prone CT scan


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Bedford Hospital
    Kempston Rd
    Bedford
    MK42 9DJ
  • Cambridge University Hospitals NHS Foundation Trust
    Addenbrooke's Hospital
    Cambridge
    CB2 0QQ
  • North West Anglia NHS Trust
    Hinchingbrooke Hospital
    Huntingdon
    PE29 6NT
  • East & N Herts NHS Trust
    Lister Hospital
    Stevena
    SG1 4AB
  • West Suffolk NHS Foundation Trust
    West Suffolk Hospital
    Bury St Edmunds
    IP33 2QZ

Possible benefits are that patients may receive earlier diagnosis and treatment of osteoporosis. There are no risks to being part of this study.

Dr Kenneth Poole


Mrs Karen Willoughby
+44 (0)1223 217580
kw369@medschl.cam.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 Cambridge University NHS Foundation Trust and funded by National Institute for Health Research.




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Read full details for Trial ID: ISRCTN14722819

Or CPMS: 41112

Last updated 29 July 2024

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