Opportunistic Fragility Fracture Risk Estimates From Radiographs

University of Exeter497 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

497

Conditions

Osteoporosis

Interventions

IbexBH SoftwareDEVICE

A software application applied to radiographs

Eligibility

Medical Language ↔ Plain English

For the collection of test data in the study. Inclusion Criteria: * Male or female * 50 years of age or over Exclusion Criteria: * 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. Inclusion Criteria: * Male or female * 20-30 years of age Exclusion Criteria: * Women who are pregnant or are breastfeeding. * Participants who have sustained fractures in both hips. * Unwilling or unable to provide informed consent.

Outcomes

Primary Outcomes

T-scores as calculated by IbexBH and DXA

Time frame: 2 hours on 1 visit only

Secondary Outcomes

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

Time frame: 2 hours on same visit as above