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.
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
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
1,146
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.
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Holland Orthopaedic & Arthritic Centre
Toronto, Ontario, Canada
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.
Time frame: 9 months
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.
Time frame: 9 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.