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

Abstract

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.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

ISCRTN: 14722819

Clinical Protocols

https://bmjopen.bmj.com/content/12/5/e050343

Funding Statement

This research was co-funded by the NIHR RfPB programme and NIHR Cambridge Biomedical Research Centre. Direct funding for PHOENIX-f was from the National Institute for Health and Care Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number NIHR RfPB/ PB-PG-0816-20027) with additional infrastructure support provided by NIHR Cambridge Biomedical Research Centre (DDGC and KESP). APW & HR (both University of East Anglia) are supported by the National Institute for Health and Care Research (NIHR) Applied Research Collaboration East of England (NIHR ARC EoE) at Cambridgeshire and Peterborough NHS Foundation Trust. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

National Research Ethics Service East of England committee gave approval for this study: REF/19/EE/0176

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

Data are available on reasonable request. Applications for access to the final trial dataset will be through the Trial Management Group (TMG) following a controlled access model (openly available to all applicants) as set out in the MRC and NIHR guidance (https://www.methodologyhubs.mrc.ac.uk/files/7114/3682/3831/Datasharingguidance2015.pdf).

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