MedPath

Opportunistic Fragility Fracture Risk Estimates From Radiographs

Recruiting
Conditions
Osteoporosis
Registration Number
NCT06110442
Lead Sponsor
University of Exeter
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
552
Inclusion Criteria
  • Male or female
  • 50 years of age or over
Read More
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.
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
T-scores as calculated by IbexBH and DXA2 hours on 1 visit only
Secondary Outcome Measures
NameTimeMethod
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

Trial Locations

Locations (1)

University of Exeter

🇬🇧

Exeter, United Kingdom

© Copyright 2025. All Rights Reserved by MedPath