Clinical Deployment and Validation of Rho

NCT05245851 | Completed

• 1 other identifier: Rho_Pilot_PPV_341462
• Study Type: interventional
• Target: 1,146
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Low Bone Density

Keywords

osteoporosis; opportunistic; radiography; DXA

Outcome Measures

Primary Outcomes (1)

• Positive predictive value

  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 Outcomes (1)

• DXA conversion

  9 months

Other Outcomes (2)

• Radiologist adoption

  2 months

• Fracture risk assessment tool (FRAX) scores

  9 months

Study Arms (1)

Opportunistic screening for low BMD

EXPERIMENTAL

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

Interventions

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.

Opportunistic screening for low BMD

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• age \< 50 years
• inpatient

Sponsors & Collaborators

• 16 Bit Inc.: lead
• Amgen: collaborator
• Sunnybrook Health Sciences Centre: collaborator

Study Sites (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Holland Orthopaedic & Arthritic Centre

Toronto, Ontario, M4Y 1H1, Canada

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Anastasia Oikonomou, MD, PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 16 Bit intends to study the impact of RhoTM by performing a prospective trial to assess its impact. A selected pilot site must have both x-ray and dual energy x-ray absorptiometry (DXA) imaging services, with the anticipation that DXA referrals will be made to the same imaging center which performed the x-ray which underwent RhoTM screening. The study population to assess the impact of RhoTM will consist of patients aged 50 and above who are opportunistically screened by RhoTM while undergoing an x-ray of the lumbar spine, thoracic spine, hand, knee, pelvis or chest.

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 18, 2022
• Study Start: November 21, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)