Atypical Femur FractureNCT01747304
Evaluation of IVA (SE Femur Scans) to Identify Incomplete AFFs
An observational study of Atypical Femur Fracture, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
DXA scanners are routinely used to assess bone mineral density (BMD) and fracture risk in osteoporosis patients. They provide detailed bone imaging in a low radiation setting. Hologic manufactures scanners that are able to perform high definition instant vertebral fracture assessment (HD-IVA) used to screen at-risk… Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atypical Femur Fracture
- What is being tested?
- DXA Se femur scans (previously called IVA femur)
- Type of treatment
- Medical device
- How many people
- 285 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2012to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Osteoporosis/Bone Mineral Density Lab out-patients
Who may be able to join
- Known AFF group
- A subject must have experienced an incomplete atypical low trauma fracture of the femoral shaft;
- Is a patient at the UHN osteoporosis clinic.
- Comparison Group
- Must be scheduled for a bone mineral density scan at UHN
- Have been on any bisphosphonate for 5 years or longer, and;
- Have unexplained symptoms of leg, hip, thigh, or knee pain.
Who cannot join
- There are no exclusions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Dual Energy X-ray Absorptiometry Scanners in the Identification of Atypical Femur Fractures - A Validation Study
DXA scanners are routinely used to assess bone mineral density (BMD) and fracture risk in osteoporosis patients. They provide detailed bone imaging in a low radiation setting. Hologic manufactures scanners that are able to perform high definition instant vertebral fracture assessment (HD-IVA) used to screen at-risk patients for asymptomatic spine fractures instantly and reliably at the same time they are having their yearly BMD. We wish to investigate whether this same proven technology (HD-IVA scan mode) used on femurs (the scan mode is now called SE Femur scans) can be used to screen for atypical fractures of the femur in patients at risk for these debilitating fractures. In this proof of concept study, we propose to examine whether DXA scanners can provide a sensitive low radiation screening method to identify incomplete AFFs in patients with known incomplete AFFs and in patients at risk.
- Conditions
- Atypical Femur Fracture
- Being tested
- DXA Se femur scans (previously called IVA femur)
- Keywords
- Atypical Femur Fracture, DXA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXA Se femur scans (previously called IVA femur)Device
Also called SF Femur scans
Single Energy Beam (previously called inter-vertebral assessment) by Dual energy x-ray absorptiometry of affected femur
| Study group | Role | What they receive |
|---|---|---|
| Screening population | Healthy post-menopausal women attending bone mineral density screening clinic with leg/hip/groin pain/discomfort/weakness an has been on anti-resorptive therapy for at least 5 years. Receives: Device: DXA Se femur scans (previously called IVA femur) | |
| Comparator Group | Control group from Toronto CaMOS cohort willing to participate. Receives: Device: DXA Se femur scans (previously called IVA femur) | |
| AFF group | participants in the AFF Cohort study at UHN Receives: Device: DXA Se femur scans (previously called IVA femur) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HD-IVA visualization of incomplete femur fractures
Hologic DXA scanner using the high-definition IVA (HD-IVA) mode on femur bones will be able to visualize incomplete femur fractures at least 90% of the time in patients with known incomplete AFF.
Measured: 1 day (one time point )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atypical Femur FractureStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela M Cheung, MD, PhD, CCD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747304
- Sponsor's protocol ID
- 12-0352
- Status last verified
- Aug 2025
- First submitted
- 7 Dec 2012
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dual Energy X-ray Absorptiometry Scanners in the Identification of Atypical Femur Fractures - A Validation Study
- ClinicalTrials.gov ID
- NCT01747304
- Acronym / sponsor ID
- 12-0352
- Conditions
- Atypical Femur Fracture
- Keywords
- Atypical Femur Fracture, DXA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 285 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Dec 2012 (estimated)
- 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.
DXA scanners are routinely used to assess bone mineral density (BMD) and fracture risk in osteoporosis patients. They provide detailed bone imaging in a low radiation setting. Hologic manufactures scanners that are able to perform high definition instant vertebral fracture assessment (HD-IVA) used to screen at-risk patients for asymptomatic spine fractures instantly and reliably at the same time they are having their yearly BMD. We wish to investigate whether this same proven technology (HD-IVA scan mode) used on femurs (the scan mode is now called SE Femur scans) can be used to screen for atypical fractures of the femur in patients at risk for these debilitating fractures. In this proof of concept study, we propose to examine whether DXA scanners can provide a sensitive low radiation screening method to identify incomplete AFFs in patients with known incomplete AFFs and in patients at risk.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Screening population | – | Device: DXA Se femur scans (previously called IVA femur)Healthy post-menopausal women attending bone mineral density screening clinic with leg/hip/groin pain/discomfort/weakness an has been on anti-resorptive therapy for at least 5 years. |
| Comparator Group | – | Device: DXA Se femur scans (previously called IVA femur)Control group from Toronto CaMOS cohort willing to participate. |
| AFF group | – | Device: DXA Se femur scans (previously called IVA femur)participants in the AFF Cohort study at UHN |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Osteoporosis/Bone Mineral Density Lab out-patients
Key inclusion criteria (7 listed)
- Known AFF group
- A subject must have experienced an incomplete atypical low trauma fracture of the femoral shaft;
- Is a patient at the UHN osteoporosis clinic.
- Comparison Group
- Must be scheduled for a bone mineral density scan at UHN
Key exclusion criteria (1 listed)
- There are no exclusions
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 |
|---|---|---|
| DXA Se femur scans (previously called IVA femur)Also: SF Femur scansSingle Energy Beam (previously called inter-vertebral assessment) by Dual energy x-ray absorptiometry of affected femur | Device | AFF group, Comparator Group, Screening population |
Primary outcome
HD-IVA visualization of incomplete femur fractures
Time frame: 1 day (one time point )
Hologic DXA scanner using the high-definition IVA (HD-IVA) mode on femur bones will be able to visualize incomplete femur fractures at least 90% of the time in patients with known incomplete AFF.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
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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.
Angela M Cheung, MD, PhD, CCD principal investigator
University Health Network, Toronto
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 Atypical Femur Fracture, run by University Health Network, Toronto at 1 site in Canada.
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 7 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
HD-IVA visualization of incomplete femur fractures (time frame: 1 day (one time point )). 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 19 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.