Opportunistic Fragility Fracture Risk Estimates From Radiographs
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoporosis
- Sponsor
- University of Exeter
- Enrollment
- 497
- Locations
- 1
- Primary Endpoint
- T-scores as calculated by IbexBH and DXA
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
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)(2 hours on same visit as above)