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
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The PHOENIX-f (Picking up Hidden Osteoporosis Effectively during Normal CT Imaging without additional X-rays) feasibility study determined the future evaluability of one-stop osteoporosis screening in patients undergoing computed tomography (CT) scans relating to other conditions. To improve identification and treatment rates amongst higher fracture risk older patients, we conducted a feasibility randomised controlled trial to help plan a definitive trial. We sought to determine ability to randomise and collect follow-up measures. We further sought to estimate this population’s osteoporosis and vertebral fracture prevalence, and treatment rates.
In one teaching hospital and four regional UK hospital radiology waiting areas, patients undergoing abdomen ± pelvis CT scans (women aged ≥65, men aged ≥75) areas were offered ‘FRAX’ fracture risk questionnaires with embedded consent forms for voluntary completion. 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 (GPs); 2) FRAX answers sent to GPs; 3) usual care (GP informed of participation).
Co-primary feasibility endpoints were to randomise 375 patients within 10 months and retain 75% of survivors for a 1-year bone health outcome questionnaire. 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. Suggested benefits of the CliniQCT screening pathway warrant further effectiveness and cost-effectiveness evaluation.
Lay summary
Whole body CT scanners are frequently used to find and track various diseases. We tested a new treatment pathway that re-uses scans to additionally spot people with weak bones (osteoporosis) or broken bones in the spine – where seen, GPs are told and given advice about treatment. To see if we could comprehensively test this new pathway in future, we conducted a ‘feasibility study’ comparing it to current forms of treatment. Good numbers of people of people joined the study and kept returning questionnaires. This suggests a future study testing how well the pathway works, and how costs compare, is achievable.
