Opportunistic Fragility Fracture Risk Estimates From Radiographs (OFFER2)

October 31, 2023 updated by: University of Exeter

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

552

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Representative population

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
T-scores as calculated by IbexBH and DXA
Time Frame: 2 hours on 1 visit only
2 hours on 1 visit only

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 hours on same visit as above

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Exeter

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 326406

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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