Opportunistic Fragility Fracture Risk Estimates From Radiographs

Osteoporosis Clinical Trial

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Official title:

Opportunistic Fragility Fracture Risk Estimates From Radiographs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06110442
• Other study ID #: 326406
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: October 2023
• Source: University of Exeter
• Contact: Robert Meertens, PhD
• Phone: (0044)01392722511
• Email: R.M.Meertens[@]exeter.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 552
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Device:
• IbexBH Software
A software application applied to radiographs

Locations

Country	Name	City	State
United Kingdom	University of Exeter	Exeter

Sponsors (1)

Lead Sponsor	Collaborator
University of Exeter

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T-scores as calculated by IbexBH and DXA		2 hours on 1 visit only
Secondary	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