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Software
Opportunistic screening for low BMD for Osteoporosis
N/A
Recruiting
Led By Anastasia Oikonomou, MD, PhD
Research Sponsored by 16 Bit Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
Study Summary
This trial will assess the ability of a software, RhoTM, to accurately identify patients with low bone mineral density (BMD). RhoTM is designed as a pre-screening tool for osteoporosis, a disease characterized by loss of BMD. The trial will analyze the performance and impact of RhoTM in real-world settings.
Eligible Conditions
- Osteoporosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Positive predictive value
Secondary outcome measures
DXA conversion
Other outcome measures
Fracture risk assessment tool (FRAX) scores
Radiologist adoption
Trial Design
1Treatment groups
Experimental Treatment
Group I: Opportunistic screening for low BMDExperimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreOTHER
656 Previous Clinical Trials
1,549,422 Total Patients Enrolled
2 Trials studying Osteoporosis
440 Patients Enrolled for Osteoporosis
AmgenIndustry Sponsor
1,370 Previous Clinical Trials
1,376,488 Total Patients Enrolled
55 Trials studying Osteoporosis
550,673 Patients Enrolled for Osteoporosis
16 Bit Inc.Lead Sponsor
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings available to join this medical experiment?
"According to clinicaltrials.gov, this trial is not presently enlisting patients. Originally posted on September 1st 2022 and last edited July 13th 2022, it has currently ceased recruitment though there are 40 other studies that need participants at this time."
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