Validating Osteoporosis Detection in Rho AI Software

To assess the effectiveness of 16bit's Rho AI (artificial intelligence) software at identifying known cases of osteoporosis. 800 de-identified images from January 2007 to January 2024 will be accessed to test the software prospectively.

Completed

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Key information

Conditions

Osteopenia or Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UW School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

About this study

Osteoporosis is underrecognized and undertreated in the orthopedic surgery patient population. Osteoporosis is diagnosed by dual-energy x-ray absorptiometry which is costly and imparts radiation. Preoperative radiographs are universally obtained in orthopedic surgery patients, however up to this point radiographs have not been able to diagnose osteoporosis. This software program is a new technology that is able to leverage radiographs to opportunistically screen for osteoporosis.

The study team will identify applicable patient records from medical record review, and Radius will de-identify the x-ray images. The de-identified images will be run through the Rho AI program to identify osteoporosis or osteopenia, and a report will be generated to summarize the program's findings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

images from people who have undergone total joint arthroplasty
images from people who have undergone spine fusion

Exclusion criteria

Treatment and study plan

Rho AI software

Device

Rho is a AI enabled opportunistic pre-screening computer-aided detection and notification software for low bone mineral density.

Primary outcomes

AI Predicted Osteoporosis Score

Time frame: through study completion (data collected up to 1 month)

Osteoporosis score is a T-score where -1.0 and above: Normal bone density, -1.0 to -2.5: Osteopenia (low bone mass), -2.5 and below: Osteoporosis

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Feb 17, 2025
Registry last updated: Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed