Validating Osteoporosis Detection in Rho AI Software | NCT06830005

Studies
Validating Osteoporosis Detection in Rho AI Software

NCT06830005

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Jan 15, 2026Actual

Enrollment

800Actual

Phase

Not Applicable

Conditions

Osteopenia or Osteoporosis

Interventions

Rho AI software

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
A536100	Other Identifier	UW Madison
Protocol Version	Other Identifier	UW Madison

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2025Actual

Primary Completion Date

Dec 1, 2025Actual

Completion Date

Dec 1, 2025Actual

First Submitted Date

Feb 11, 2025

First Submission Date that Met QC Criteria

Feb 11, 2025

First Posted Date

Feb 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2026

Last Update Posted Date

Jan 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

800Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Detection of Osteoporosis	Experimental		Device: Rho AI software

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rho AI software	Device	Rho is a AI enabled opportunistic pre-screening computer-aided detection and notification software for low bone mineral density.	Experimental Detection of Osteoporosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AI Predicted Osteoporosis Score	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	through study completion (data collected up to 1 month)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James Bernatz, MD	UW School of Medicine and Public Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UW School of Medicine and Public Health		Madison	Wisconsin	53792	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001851	Bone Diseases, Metabolic
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided