Opportunistic Fragility Fracture Risk Estimates From Radiographs

NCT06110442 | Completed

• 1 other identifier: 326406
• Study Type: observational
• Target: 497
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study will predict a patients' risk of having osteoporosis by using a combination of the IBEX BH (Bone Health) software outputs and other clinical risk factors such as age, gender, medical history and lifestyle. A comparison will be made between the IBEX BH prediction and the one calculated in current clinical practice using a tool called FRAX (Fracture Risk Assessment Tool) which combines clinical risk factors with results from a Dual Energy X-ray Absorptiometry (DXA) assessment. The study involves conducting these assessments on several new anatomies including Knee, Ankle and Pelvis, to extend the market reach and clinical utility of IBEX BH. The expected outcome of the study is that the IBEX BH will offer better decision support to clinicians in terms of referral on for a DXA scan or osteoporosis investigations than available today.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• T-scores as calculated by IbexBH and DXA

  2 hours on 1 visit only

Secondary Outcomes (1)

• Estimated 10-year risk of major osteoporotic fracture as outputted by FRAX (with and without DXA aBMD (Areal Bone Mineral Density) and IbexBH)

  2 hours on same visit as above

Interventions

IbexBH Software DEVICE

A software application applied to radiographs

Eligibility Criteria

• Age: 20 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Representative population

You may qualify if:

• Male or female
• years of age or over

You may not qualify if:

• Women who are pregnant or are breastfeeding.
• Participants who have sustained fractures in both hips.
• Unwilling or unable to provide informed consent.
• For the collection of healthy-normal data in the study.
• Male or female
• years of age
• Women who are pregnant or are breastfeeding.
• Participants who have sustained fractures in both hips.
• Unwilling or unable to provide informed consent.

Sponsors & Collaborators

• University of Exeter: lead

Study Sites (1)

University of Exeter

Exeter, United Kingdom

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 31, 2023
• Study Start: July 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)