Opportunistic Fragility Fracture Risk Estimates From Radiographs (OFFER2)

University of Exeter

Status: Completed

Conditions: Osteoporosis

Treatments: Device: IbexBH Software

Study type: Observational

Funder types: Other

Identifiers

NCT06110442

326406

Details and patient eligibility

About

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.

Enrollment: 497 patients

Sex: All

Ages: 20 to 120 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.