Clinical Deployment and Validation of Rho

January 23, 2023 updated by: 16 Bit Inc.

Clinical Deployment and Validation of Rho - An Opportunistic Osteoporosis Screening Software-as-a-Medical Device

Osteoporosis is a widespread disease characterized by the loss of bone mineral density (BMD). 16 Bit has developed software, called RhoTM, that analyzes various x-rays, performed in patient age 50 and above for any clinical indication, to identify patients with low BMD. RhoTM is intended to function as a pre-screening device for low BMD. This study seeks to assess the clinical performance and impact of implementing RhoTM in real-world settings by analyzing its performance and impact on DXA referrals.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Osteoporosis is a widespread disease characterized by the loss of bone mineral density (BMD). 16 Bit has developed an opportunistic screening tool for low BMD, called RhoTM, that analyzes lumbar spine, thoracic spine, chest, pelvis, knee, and hand radiographs, performed in patient age 50 and above for any clinical indication to estimate lumbar and femoral neck BMD. The estimated BMD T-score is used to classify patients as having normal or low BMD. A finding of low BMD can be included in a radiologist's report, and is intended to support a discussion between healthcare provider and patient regarding the need for osteoporosis diagnosis by dual-energy x-ray absorptiometry (DXA). In this way, RhoTM is intended to function as an opportunistic pre-screening device for low BMD. This study seeks to assess the clinical performance and impact of implementing RhoTM in real-world settings by analyzing the diagnostic performance and impact on DXA referrals.

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Not Applicable

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Anastasia Oikonomou, MD, PhD
      • Toronto, Ontario, Canada, M4Y 1H1
        • Recruiting
        • Holland Orthopaedic & Arthritic Centre
        • Principal Investigator:
          • Anastasia Oikonomou, MD, PhD
        • Contact:

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 50+ years
  • outpatient undergoing x-ray examinations of:
  • chest
  • thoracic spine
  • lumbar spine
  • pelvis
  • knee
  • hand/wrist

Exclusion Criteria:

  • age < 50 years
  • inpatient

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

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Opportunistic screening for low BMD
Outpatients aged over 50 years undergoing x-ray of the thoracic spine, lumbar spine, chest, pelvis, hand or knee will have their x-rays screened for low BMD by the software-as-a-medical device. If low BMD is identified by the software, a radiologist reviewing the x-ray may choose to incorporate this as an incidental finding in their report to the referring physician.
Device: Opportunistic screening for low BMD

Software will analyze x-rays of the chest, thoracic spine, lumbar spine, pelvis, knee or hand/wrist acquired for any reason, and notify the radiologist at time of acquisition if low BMD is detected. The report to the radiologist includes the following statements:

  • This x-ray was opportunistically analyzed by RhoTM, an investigational device under ITA [investigational testing authorization] from Health Canada, to screen for low bone mineral density (low BMD).
  • This information should be used by a trained healthcare provider in conjunction with a patient's clinical fracture risk to determine if formal BMD screening with DXA is appropriate.

The radiologist can choose to include this as an incidental finding in their report to the referring physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive predictive value
Time Frame: 9 months
To measure the positive screening rate for all patients screened by RhoTM and the positive predictive value (PPV) in those patients who screen positive by RhoTM and undergo follow-up DXA. PPV will be assessed for identification of low BMD (T-score <-1) and for identification of moderate/high fracture risk.
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DXA conversion
Time Frame: 9 months
To assess the DXA conversion rate defined as the proportion of patients who have a DXA within 6 months following a positively reported RhoTM screen. Scheduled DXA examinations may be used as a surrogate.
9 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiologist adoption
Time Frame: 2 months
To assess radiologist adoption rate defined as the number of patients who are screened positive by RhoTM and for which the radiologist has included the findings of RhoTM in their report (i.e. a positively reported RhoTM screen) divided by the total number of positive RhoTM screens.
2 months
Fracture risk assessment tool (FRAX) scores
Time Frame: 9 months
To compare the 10-year FRAX score as calculated using a DXA-derived T-score versus a Rho-derived T-score.
9 months

Collaborators and Investigators

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

Sponsor

16 Bit Inc.

Collaborators

Sunnybrook Health Sciences Centre
Amgen

Investigators

  • Principal Investigator: Anastasia Oikonomou, MD, PhD, Sunnybrook Health Sciences Centre

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 (Actual)

November 21, 2022

Primary Completion (Anticipated)

July 21, 2023

Study Completion (Anticipated)

July 21, 2023

Study Registration Dates

First Submitted

February 9, 2022

First Submitted That Met QC Criteria

February 9, 2022

First Posted (Actual)

February 18, 2022

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rho_Pilot_PPV_341462

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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