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Opportunistic Fragility Fracture Risk Estimates From Radiographs - Trial NCT06110442

Access comprehensive clinical trial information for NCT06110442 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Exeter and is currently Recruiting. The study focuses on Osteoporosis. Target enrollment is 552 participants.

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NCT06110442
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Trial Details
ClinicalTrials.gov โ€ข NCT06110442
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Opportunistic Fragility Fracture Risk Estimates From Radiographs

Study Focus

Osteoporosis

IbexBH Software

Observational

device

Sponsor & Location

University of Exeter

Exeter, United Kingdom

Timeline & Enrollment

N/A

Jul 01, 2023

Sep 01, 2024

552 participants

Primary Outcome

T-scores as calculated by IbexBH and DXA

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.

ICD-10 Classifications

Osteoporosis, unspecified
Other osteoporosis
Idiopathic osteoporosis
Osteoporosis in diseases classified elsewhere
Postmenopausal osteoporosis

Data Source

ClinicalTrials.gov

NCT06110442

Device Trial