PHOENIX-f: A Randomised Controlled Feasibility Study of One- Stop Osteoporosis Screening among Patients Undergoing Routine Computed Tomography using FRAX and CliniQCT Bone Density Measurement and Vertebral Fracture Detection

Background The PHOENIX-f study examined the feasibility of: i) screening for osteoporosis in patients undergoing computed tomography (CT) scans relating to other conditions using a one-stop service across multiple hospitals and; ii) a full trial to evaluate its effectiveness and cost-effectiveness. CT scan images of older patients at higher risk of fractures were opportunistically ‘re-used' - through digital screening - to improve identification, treatment and fracture prevention. Method Randomised controlled feasibility study to inform the design of a future definitive trial by determining ability to randomise and collect follow-up measures and estimating this population’s osteoporosis and vertebral fracture prevalence, and treatment rates. Patients from one teaching hospital and four regional UK hospital radiology waiting areas undergoing abdomen ± pelvis CT scans (women aged ≥65, men aged ≥75) were offered ‘FRAX’ fracture risk questionnaires with embedded consent forms. Consenting patients identified as having moderate/high 10-year fracture risk based on initial screening (FRAX red/amber zones) were randomised (1:1:1) to: 1) CliniQCT One-Stop osteoporosis screening pathway [vertebral fracture assessment and hip/spine BMD measurement by applying Mindways QCT and SlicePick-MT software to CT scans, plus algorithm-based recommendations sent by electronic letter to general practitioners]; 2) FRAX answers sent to GPs; 3) usual care (GP informed of participation). Results From 1,828 eligible for invitation, 595 participants consented; low FRAX scores excluded 213 patients. Outcomes achieved included randomising 382 patients within 10 months and 284/329 survivors (86%) completing 1-year follow-up. Of 356 analysable CT scans osteoporosis was diagnosed in 42%. 46/258 (18%) whole thoraco-lumbar scans showed vertebral fractures. At follow-up 36%, 26% and 8% of patients needing osteoporosis treatment in the screened, FRAX-only and usual care groups respectively reported taking treatment. Collecting data needed for a future economic evaluation to determine cost-effectiveness appeared feasible. Conclusions Both the CliniQCT screening pathway, and a trial to determine its effectiveness and cost-effectiveness, were shown to be feasible. Even within this small sample, we found relatively high rates of osteoporosis and a signal suggesting that CliniQCT could facilitate its treatment, warranting a full trial evaluation. Trial registration ISCRTN: 14722819 DOI https://doi.org/10.1186/ISRCTN14722819 Secondary identifying numbers: PB-PG-0816-2007; CPMS: 41112