Clinical trial NCT05245851: Clinical Deployment and Validation of Rho
Official title: Clinical Deployment and Validation of Rho - An Opportunistic Osteoporosis Screening Software-as-a-Medical Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Bone Density
Keywords: osteoporosis
opportunistic
radiography
DXA
Lead sponsor: 16 Bit Inc.
Sponsor class: INDUSTRY
Collaborators: name: Amgen
name: Sunnybrook Health Sciences Centre
First posted: 2022-02-18
Enrollment: 1200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Positive predictive value
timeFrame: 9 months
Secondary outcomes:
measure: DXA conversion
timeFrame: 9 months
Other outcomes:
measure: Radiologist adoption
timeFrame: 2 months
measure: Fracture risk assessment tool (FRAX) scores
timeFrame: 9 months
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Holland Orthopaedic & Arthritic Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Anastasia Oikonomou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: