NCT06830005

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

February 11, 2025

Last Update Submit

January 14, 2026

Conditions

Osteopenia or Osteoporosis

Keywords

orthopedic surgeryscreening

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

Experimental Detection of Osteoporosis

EXPERIMENTAL
Device: Rho AI software

Interventions

Rho AI softwareDEVICE

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

Experimental Detection of Osteoporosis

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UW School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Bone Diseases, MetabolicOsteoporosis

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • James Bernatz, MD

    UW School of Medicine and Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 17, 2025

Study Start

June 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)