OsteoPorosis Treatment Identification Using Machine Learning (OPTIMAL)

January 4, 2023 updated by: NHS Greater Glasgow and Clyde

OPTIMAL - OsteoPorosis Treatment Identification Using Machine Learning

OPTIMAL is a pilot feasibility study for a machine learning (ML) based enhanced screening software for osteoporosis.

This tool has been created using machine learning, based on data from NHS Greater Glasgow and Clyde. The study will contact individuals deemed at high risk by the study (750 patients will be re-identified, and these will be contacted starting from the highest risk until 250 patients are recruited) and perform DXA scans, clinical review, and bloods tests that are relevant to osteoporosis. This data will then be compared to the predictions made by the OPTIMAL enhanced screening tool, in order to test how effective it is.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The OPTIMAL trial is a feasibility pilot study for an enhanced screening method using a tool developed using machine learning. This tool has been created by Lenus Health Ltd using anonymised health data from NHS GG&C of patients between the age of 50 and 80 as of 1st of January 2010.

The validation cohort will include all patients in GG&C between the ages of 50 and 80 as of 1st January 2022 who are not known to have a diagnosis of osteoporosis.

Nanox (Israeli AI company) will use their existing platform to analyse de-identified CT scans of the 5000 patients identified as highest risk in this population to asses for vertebral fracture, which will be used as a parameter in risk assessment for osteoporosis. Because of technical limitations, only a selection of patients can have their imaging assessed by the Nanox platform. The 5000 highest risk patients will be reidentified so that their images can be extracted and de-identified for analysis. We expect approximately 30% of these patients will have available imaging. Identifiable data will remain within the GG&C cloud.

The trial will use the software to screen for patients at high risk within a cohort of patients aged 50-80 without a diagnosis of osteoporosis. DXA scanning will be used as a ground truth. Patients will have DXA scanning as part of the trial.

There will be a clinical review to remove patients that are felt to be inappropriate for the trial, such as people approaching the end of life, or unable to give consent. The reason for exclusion will be recorded to allow auditing and assessing for bias in selection.

Patients, starting with those at highest risk, will then be contacted by the Fracture Liaison Service until 250 have been recruited. This number has been reached based on power calculations to ensure this trial can effectively compare the OPTIMAL tool with FRAX. This contact will be in the form of a letter from the fracture liaison team, and will come with a patient information sheet and consent form. These forms have been created with the input of a patient experience group.

The participant, should they agree to partake, will then be invited for a single clinic visit at the Queen Elizabeth University Hospital.

At this visit, a doctor will review the patient, and ask questions about their health. They will have blood tests which are relevant to osteoporosis, as well as general health. They will also have a DXA scan to confirm if they do or do not have osteoporosis. A FRAX score will be generated for the purposes of comparison.

Upon completion of data cleaning, at the end of the trial, all data will be transferred The University of Strathclyde secure servers for analysis by Dr Conor McKeag, with oversight from Dr David Young to assess the efficacy and accuracy of the OPTIMAL tool. This will be compared to FRAX, the current standard for risk prediction in osteoporosis.

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients between the ages of 50 and 80 identified as high risk by the initial model, without a diagnosis of osteoporosis, hyperparathyroidism, or other metabolic bone disease

Description

Inclusion Criteria:

  • Age >=50y
  • Age <=80y
  • Identified as high risk by initial model

Exclusion Criteria:

  • Age <50y
  • Age >80y
  • BMI <=18 & >=30
  • Recorded diagnosis of osteoporosis
  • Prior prescription of bone protective agents such as:

bisphosphonate (alendronic acid, risedronate, ibandronate, zoledronic acid) / denosumab / raloxifene / strontium ranelate / teriparatide / romosozumab

  • History of prior DXA imaging (prior quantification of BMD)
  • History of metabolic bone disease
  • History of primary hyperparathyroidism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High Risk Group
Group identified by machine learning model as being at high risk of developing osteoporosis.
Diagnostic test: Dual Energy Xray Absorptiometry
DXA for diagnosis of osteoporosis
Other Names:
  • DEXA
  • DXA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Osteoporosis Diagnosis
Time Frame: At first visit, within 6 months of patient identification.
Diagnosis of Osteoporosis based on DXA assessment of bone mineral density at Clinical Visit. This will be done at the single clinical visit as part of the trial and will not be repeated.
At first visit, within 6 months of patient identification.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

January 1, 2023

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Estimate)

January 10, 2023

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPTIMAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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