Opportunistic Fragility Fracture Risk Estimates From Radiographs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

497 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoporosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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IbexBH Software

A software application applied to radiographs

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female
* 50 years of age or over

* 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.

For the collection of healthy-normal data in the study.

* Women who are pregnant or are breastfeeding.
* Participants who have sustained fractures in both hips.
* Unwilling or unable to provide informed consent.

Minimum Eligible Age

20 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes