Skip to main content
OpenTrials
Completed

NCT Number: NCT06110442

Opportunistic Fragility Fracture Risk Estimates From Radiographs

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

20 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Exeter

Exeter, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IbexBH Software

Device

A software application applied to radiographs

Primary outcomes

  1. T-scores as calculated by IbexBH and DXA

    Time frame: 2 hours on 1 visit only

Secondary outcomes

  1. Estimated 10-year risk of major osteoporotic fracture as outputted by FRAX (with and without DXA aBMD (Areal Bone Mineral Density) and IbexBH)

    Time frame: 2 hours on same visit as above

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Registry information

Acronym: OFFER2

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 31, 2023
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.