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Completed

NCT Number: NCT05245851

Clinical Deployment and Validation of Rho

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.

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Key information

Conditions

Low Bone Density Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Holland Orthopaedic & Arthritic Centre, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opportunistic screening for low BMD

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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. 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.

Sponsors and collaborators

Lead sponsor

16 Bit Inc.

Industry

Collaborators

  • Amgen
  • Sunnybrook Health Sciences Centre

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 18, 2022
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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