Clinical Deployment and Validation of Rho

Low Bone Density Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05245851
• Other study ID #: Rho_Pilot_PPV_341462
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2022
• Est. completion date: July 21, 2023

Study information

• Verified date: January 2023
• Source: 16 Bit Inc.
• Contact: Regis Manorajah
• Phone: 416-480-6100
• Email: regis.manorajah[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: July 21, 2023
• Est. primary completion date: July 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Low Bone Density

Intervention

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.

Locations

Country	Name	City	State
Canada	Holland Orthopaedic & Arthritic Centre	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
16 Bit Inc.	Amgen, Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Radiologist adoption	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
Other	Fracture risk assessment tool (FRAX) scores	To compare the 10-year FRAX score as calculated using a DXA-derived T-score versus a Rho-derived T-score.	9 months
Primary	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	DXA conversion	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