OsteoporosisNCT07487688
Five-Year CT Follow-Up of Vertebral Fracture Risk Using Opportunistic Osteoporosis Screening
An observational study of Osteoporosis and Fracture Risk Assessment, run by Technical University of Munich at 1 site in Germany.
Trial summary
This study evaluates whether opportunistic osteoporosis screening using routinely acquired computed tomography (CT) scans improves fracture risk prediction compared with guideline-recommended FRAX-based screening from age 50. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoporosis, Fracture Risk Assessment, Osteoporotic Fracture of Vertebra
- What is being tested?
- Opportunistic osteoporosis screening
- How many people
- 2,799 participants
- Where
- 1 siteGermany
- Study dates
- 25 Feb 2003to 15 Oct 2021
- 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 40 years and older
- All sexes
- Adult, Older adult
Study population: Consecutive patients from the local imaging database that received a CT scan including at least T6 to L4 (=baseline) and a second CT scan after at least 5 years including at least T6 to L4 (=5 years follow-up)
Who may be able to join
- Baseline CT and 5 years follow-up CT including parts of the lumbar spine
Who cannot join
- CT: No sagittal reformations or axial slices ≤3 mm
- CT: No inclusion of at least T6 to L4
- No BMI data available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CTFU: Five-Year Computed Tomography Follow-Up Study of Vertebral Fracture Risk Using Opportunistic Screening for Osteoporosis
This study evaluates whether opportunistic osteoporosis screening using routinely acquired computed tomography (CT) scans improves fracture risk prediction compared with guideline-recommended FRAX-based screening from age 50. In current practice, few high-risk individuals identified by FRAX actually receive confirmatory dual-energy X-ray absorptiometry (DXA), despite the growing health and economic burden of osteoporotic fractures. Volumetric bone mineral density (vBMD) and CT-based detection of vertebral fractures can be extracted from existing CT images obtained for other indications, offering a non-invasive way to capture key determinants of fracture and mortality risk, including low BMD, age, and prevalent fractures. The trial therefore compares the diagnostic performance of FRAX major osteoporotic fracture risk versus CT-derived vBMD and CT-identified vertebral fractures for predicting incident vertebral fractures in older adults.
Read the detailed description
Primary objective: To assess the predictive performance of opportunistic volumetric bone mineral density (vBMD) from routine thoracoabdominal CT scans for incident vertebral fractures over 5 years or longer.
Secondary objectives:
- To compare the performance of vBMD to predict incident vertebral fractures with other predictors, including demographic and clinical risk factors, FRAX algorithm scores for 5-year risk of major osteoporotic fractures (MOF), prevalent vertebral fractures, and prevalent clinical fractures, as well as combinations of these predictors.
- To stratify the analyses based on age decades and sex.
- To compare the predictive performance between CT scans with and without administration of i.v. contrast medium.
- To compare the predictive performance of vBMD (using asynchronous calibration) with Hounsfield units
- To describe the prevalence and incidence (in fractures per person-years) of the study population
- Assessment of the impact of a preventive treatment of patients at high risk of fracture in terms of the number of avoided fractures (simulation study)
- Being tested
- Opportunistic osteoporosis screening
- Keywords
- Osteoporosis, Opportunistic Screening, Vertebral Fractures, Computed Tomography, Bone Mineral Density, Fracture Risk Assessment
- Medical subject headings
- Osteoporosis, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opportunistic osteoporosis screeningDiagnostic test
Automatic assessment of CT-based biomarkers of bone health
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident vertebral fracture
CT based detection of vertebral fractures
Measured: From enrollment to minimum 5 years follow-up
Secondary outcomes (1)
Clinical fragility fractures
Fragility fractures from medical records (retrospective)
Measured: From enrollment to maximum 10 years follow-up (upon availability)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start25 Feb 2003
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
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.
- More trials run by Technical University of MunichThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,799 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximilian Löffler, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487688
- Sponsor's protocol ID
- CTFU5YTUM
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CTFU: Five-Year Computed Tomography Follow-Up Study of Vertebral Fracture Risk Using Opportunistic Screening for Osteoporosis
- ClinicalTrials.gov ID
- NCT07487688
- Acronym / sponsor ID
- CTFU5YTUM
- Keywords
- Osteoporosis, Opportunistic Screening, Vertebral Fractures, Computed Tomography, Bone Mineral Density, Fracture Risk Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,799 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 25 Feb 2003 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 23 Mar 2026 (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.
This study evaluates whether opportunistic osteoporosis screening using routinely acquired computed tomography (CT) scans improves fracture risk prediction compared with guideline-recommended FRAX-based screening from age 50. In current practice, few high-risk individuals identified by FRAX actually receive confirmatory dual-energy X-ray absorptiometry (DXA), despite the growing health and economic burden of osteoporotic fractures. Volumetric bone mineral density (vBMD) and CT-based detection of vertebral fractures can be extracted from existing CT images obtained for other indications, offering a non-invasive way to capture key determinants of fracture and mortality risk, including low BMD, age, and prevalent fractures. The trial therefore compares the diagnostic performance of FRAX major osteoporotic fracture risk versus CT-derived vBMD and CT-identified vertebral fractures for predicting incident vertebral fractures in older adults.
Detailed description
Primary objective: To assess the predictive performance of opportunistic volumetric bone mineral density (vBMD) from routine thoracoabdominal CT scans for incident vertebral fractures over 5 years or longer.
Secondary objectives:
- To compare the performance of vBMD to predict incident vertebral fractures with other predictors, including demographic and clinical risk factors, FRAX algorithm scores for 5-year risk of major osteoporotic fractures (MOF), prevalent vertebral fractures, and prevalent clinical fractures, as well as combinations of these predictors.
- To stratify the analyses based on age decades and sex.
- To compare the predictive performance between CT scans with and without administration of i.v. contrast medium.
- To compare the predictive performance of vBMD (using asynchronous calibration) with Hounsfield units
- To describe the prevalence and incidence (in fractures per person-years) of the study population
- Assessment of the impact of a preventive treatment of patients at high risk of fracture in terms of the number of avoided fractures (simulation study)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients from the local imaging database that received a CT scan including at least T6 to L4 (=baseline) and a second CT scan after at least 5 years including at least T6 to L4 (=5 years follow-up)
Key inclusion criteria (1 listed)
- Baseline CT and 5 years follow-up CT including parts of the lumbar spine
Key exclusion criteria (3 listed)
- CT: No sagittal reformations or axial slices ≤3 mm
- CT: No inclusion of at least T6 to L4
- No BMI data available
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 |
|---|---|---|
| Opportunistic osteoporosis screeningAutomatic assessment of CT-based biomarkers of bone health | Diagnostic test | – |
Primary outcome
Incident vertebral fracture
Time frame: From enrollment to minimum 5 years follow-up
CT based detection of vertebral fractures
1 secondary outcome
Clinical fragility fractures
Time frame: From enrollment to maximum 10 years follow-up (upon availability)
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 31 Mar 2026.
- 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 and Fracture Risk Assessment, run by Technical University of Munich at 1 site in Germany.
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 1 inclusion and 3 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 31 Mar 2026. 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 Germany. 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?
Incident vertebral fracture (time frame: From enrollment to minimum 5 years follow-up). 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 31 Mar 2026.