OsteoporosisOFFER2NCT06110442
Opportunistic Fragility Fracture Risk Estimates From Radiographs
An observational study of Osteoporosis, run by University of Exeter at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- IbexBH Software
- Type of treatment
- Medical device
- How many people
- 497 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Representative population
Who may be able to join
- Male or female
- 50 years of age or over
- Male or female
- 20-30 years of age
Who cannot join
- 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.
- Women who are pregnant or are breastfeeding.
- Participants who have sustained fractures in both hips.
- Unwilling or unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Osteoporosis
- Being tested
- IbexBH Software
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbexBH SoftwareDevice
A software application applied to radiographs
What is being measured
The primary outcome is the main question the study is designed to answer.
T-scores as calculated by IbexBH and DXA
Measured: 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)
Measured: 2 hours on same visit as above
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Jul 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 497 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110442
- Sponsor's protocol ID
- 326406
- Acronym
- OFFER2
- Status last verified
- Jan 2025
- First submitted
- 20 Sep 2023
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opportunistic Fragility Fracture Risk Estimates From Radiographs
- ClinicalTrials.gov ID
- NCT06110442
- Acronym / sponsor ID
- OFFER2 / 326406
- Conditions
- Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 497 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Representative population
Key inclusion criteria (4 listed)
- Male or female
- 50 years of age or over
- Male or female
- 20-30 years of age
Key exclusion criteria (7 listed)
- 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.
- Women who are pregnant or are breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbexBH SoftwareA software application applied to radiographs | Device | – |
Primary outcome
T-scores as calculated by IbexBH and DXA
Time frame: 2 hours on 1 visit only
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T-scores as calculated by IbexBH and DXA (time frame: 2 hours on 1 visit only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.