OFFER2: Opportunistic Fragility Fracture Risk Estimates From Radiographs

• Sponsor: University of Exeter (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06110442
• Collaborator: (none)
• Enrollment: 552
• Location: 1
• Anticipated Duration (Months): 14.1
• Patients Per Site Per Month: 39.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Device: IbexBH Software

Study Design

• Study Type: Observational
• Anticipated Enrollment: 552 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Opportunistic Fragility Fracture Risk Estimates From Radiographs
• Actual Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Aug 1, 2024
• Anticipated Study Completion Date: Sep 1, 2024

Outcome Measures

Primary Outcome Measures

1. T-scores as calculated by IbexBH and DXA [2 hours on 1 visit only]

Secondary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Exeter	Exeter		United Kingdom

Sponsors and Collaborators

• University of Exeter

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Exeter
• ClinicalTrials.gov Identifier: NCT06110442
• Other Study ID Numbers: 326406
• First Posted: Oct 31, 2023
• Last Update Posted: Nov 1, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoporosis

Study Results

No Results Posted as of Nov 1, 2023