Award Title: PHOENIX-Feasibility: Picking up Hidden Osteoporosis Effectively during Normal CT Imaging without additional X-rays (Short Title: PHOENIX-F)
Funder: Department of Health and Social Care

Abstract: Following NHS screening committee advice, Shepstone and colleagues recently completed the SCOOP study, a five-year pragmatic trial of primary osteoporosis screening which reported that women ≥75 years who underwent screening had 28% fewer hip fractures than those receiving usual care3.  We now wish to screen people attending radiology departments for diagnostic computed tomography (CT) scans, because >30% have undiagnosed vertebral fractures or osteoporosis. To identify osteoporosis opportunistically, we developed PHOENIX as an innovative  one-stop  screening pathway. PHOENIX uses the same fracture risk assessment questionnaire (FRAX) as Shepstone, but here it is given to patients in the CT waiting room. We then retrieve CT images digitally, measure bone density, assess for vertebral fractures and provide a tailored bone health advice summary. PHOENIX software works on the CT scan images already performed for other reasons.   Aims   PHOENIX-F is a randomised, pragmatic feasibility study to inform a future multi-centre randomised controlled trial (RCT) investigating whether detecting osteoporosis and vertebral fractures in patients undergoing routine CT scans will improve health by reducing the burden of fractures. The primary objective is to test the feasibility of recruitment and retention of patients across five linked hospitals. We are also testing the digital links between our Addenbrooke s hub and four nearby spoke hospitals. By testing the PHOENIX pathway versus usual care, we will also derive sample size estimates to inform the definitive trial by examining the proportion of patients treated for poor bone health at twelve months in the two study arms. Scaling up to multiple UK PHOENIX hubs, the definitive trial will focus on the fracture rate and health-related costs of the PHOENIX pathway.   PHOENIX pathway   With usual care, the completed FRAX questionnaire is sent to the GP only.  With PHOENIX, an Addenbrooke's analyst calculates the ten-year fracture risk (FRAX), retrieves CT scans by NHS Image-Exchange-Portal (IEP), identifies vertebral fractures, measures spine/hip density and creates a bone health report using a NICE-compliant pre-specified algorithm that matches our standard bone density reports. The report is sent to the patients  GP, who initiates therapy and/or gives lifestyle advice.   Plan of Investigation   The study population will consist of women and men aged ≥50 attending for CT, for any reason, where the spine and/or hips are visible. Block randomisation to PHOENIX-F versus usual care will be 1:1 by age and gender within centre.  We will determine the number of eligible patients and the number actually recruited within a ten-month recruitment window. After twelve months of follow-up, we will calculate the proportion of PHOENIX pathway patients who are treated for poor bone health in each arm (in single blinded fashion), and determine participant retention. Finally, we will examine recruitment differences according to patient characteristics (e.g. age, gender and indication for scan) to plan the appropriate randomisation schedule in any future trial. Assuming 250 responders from 1250 invites (20%) the true response rate can be estimated with 2.2% precision, and we will have 80% power to detect differences of ≥7% in twelve-month overall retention rates. Recruitment rates of ≥13% and retention rates of ≥73% are stop/go criteria for a definitive trial. PHOENIX costs will be estimated from the viewpoint of the NHS and personal social services. Resources associated with PHOENIX and those that might change as a result of it will be monitored, and we will determine the completion rates of the EQ-5D-5L questionnaire at baseline, six and twelve months.    Summary of potential benefits to patients and the NHS   The UK s coordinated medical digital imaging network seems ideally suited to this opportunistic screening technology. Targeted screening may improve clinical and economic value through early diagnosis, identifying incident fractures and future fracture prevention.

Lay Abstract: Osteoporosis makes bones become porous so they break more easily. It particularly affects the spine and hips. While treatment of osteoporosis is now quite straightforward, detection is difficult.  In the UK, osteoporosis causes 200,000 vertebral fractures yearly in women and men. Since vertebral fracture pain can feel like ordinary backache, patients are often left undiagnosed, so multiple fractures are common. A computerised tomography (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. Nearly a third of those scanned have osteoporosis or vertebral fractures without knowing it. The PHOENIX pathway uses CT images to identify osteoporosis enabling early treatment and potentially preventing future fractures.   The new technology makes it simple to measure bone density quickly and identify vertebral fractures from CT images of a patient's torso or pelvis.  Measurements of the spine and hips are performed on images acquired from any CT scanner. Patients who are already attending hospital for a CT scan will be invited to participate in this trial, regardless of the reason for their scan. One group of volunteers will be allocated to the PHOENIX pathway to diagnose osteoporosis and vertebral fractures from their CT images with an appropriate therapy recommendation. The other group will follow usual care where they are asked to complete an osteoporosis risk questionnaire that is then sent to their general practitioner. The study aims to discover whether the PHOENIX pathway will lead to better osteoporosis treatment rates and fewer painful fractures. This feasibility study will allow us to evidence patients' willingness to volunteer and consent to a year's follow-up. It will also test Addenbrooke s Hospitals' capability to connect to surrounding hospitals in a  hub and spoke  model to provide the service.

Research Activity Codes: 4.4 POPULATION SCREENING
Health Categories: MUSCULOSKELETAL