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

ObjectivesThe PHOENIX-f (Picking up Hidden Osteoporosis Effectively during Normal CT Imaging without additional X-rays) 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. DesignRandomised 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 populations osteoporosis and vertebral fracture prevalence, and treatment rates. Setting, Participants and InterventionIn one teaching hospital and four regional UK hospital radiology waiting areas, patients 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 (GPs)]; 2) FRAX answers sent to GPs; 3) usual care (GP informed of participation). Main outcome measurementsCo-primary feasibility endpoints were ability to randomise 375 patients within 10 months and retain 75% of survivors for a 1-year bone health outcome questionnaire. ResultsFrom 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. ConclusionsBoth 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 registrationISCRTN: 14722819 DOI https://doi.org/10.1186/ISRCTN14722819 Secondary identifying numbers: PB-PG-0816-2007; CPMS: 41112 Summary boxWhat is already know about this topic O_LIVertebral fractures due to osteoporosis cause severe pain, increased disability and poor quality of life, are associated with higher subsequent fracture rates and mortality, yet are often not diagnosed. C_LIO_LIBone preserving treatments can reduce osteoporotic fractures, including vertebral fractures. C_LIO_LICT scans can be used to diagnose osteoporosis and vertebral fractures without additional radiation exposure but are not routinely used in this way C_LI What this study adds O_LIOpportunistic bone density screening using CliniQCT and vertebral fracture assessment is feasible in older adults identified by FRAX as at moderate/high fracture risk. C_LIO_LIOsteoporosis and vertebral fracture prevalence is high in this population: in our study sample, 42% of QCT analysed scans showed osteoporosis and 18% of full thoraco-lumbar spine CTs showed vertebral fractures. Of all participants with vertebral fractures, 42% had multiple vertebral fractures. C_LIO_LIIn this feasibility study initiation of recommended osteoporosis treatment by a year later was over 4 times higher for patients on the screening pathway than for patients receiving usual care (36% vs 8%). C_LI How this study might affect research, practice or policy O_LIEmbedding CT-based osteoporosis detection into routine imaging could markedly improve diagnosis and treatment uptake in high-risk patients and warrants full effectiveness and cost-effectiveness evaluation. C_LI