OsteoporosisCalibr-ÌNCT06454617
Calibr-Ì: Comparative Evaluation of Phantomless Calibration Methods to Quantify Bone Mineral Density for Opportunistic Analysis of CT Scans
An observational study of Osteoporosis, run by Istituto Ortopedico Rizzoli at 2 sites in 2 countries.
Trial summary
Osteoporosis is a systemic disease characterized by a reduction in bone mineral density (BMD) and qualitative alteration of the skeleton, resulting in increased bone fragility and fracture risk. The epidemiological impact of osteoporosis is extremely high. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Phantom
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Jun 2024to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will involve a population of patients undergoing CT scans including the lumbar spine at the Diagnostic and Interventional Radiology Unit of each participating center. In CT scans requiring the administration of contrast medium, only the non-contrast-enhanced images will be considered.
Who may be able to join
- Both sexes.
- All ethnicities.
- Age equal or above 18 years.
- Any clinical indication (no specific pathology is required) for a CT scan of the lumbosacral spine or abdomen in which the entire lumbar spine (L1 to L5), paravertebral muscles, abdominal aorta, and subcutaneous adipose tissue are visible.
- Ability to give informed consent.
Who cannot join
- General contraindications to CT examination, including pregnancy or body weight/size exceeding scanner limits.
- Severe degenerative manifestations of the lumbosacral spine.
- Severe scoliosis of the lumbosacral spine.
- Surgical hardware that prevents adequate CT scanning.
- Oncologic pathology in progress or in recent history.
- Any other situation deemed incompatible with the study by the designated physician or investigator.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Italy1 site, 1 recruiting
- Recruiting
The Rizzoli Orthopaedic Institute
Bologna, Bo, 40136
Alberto Bazzocchi, MD, PhD, +39 051 636 6836, abazzocchi@gmail.com
New Zealand1 site, 1 recruiting
- Not yet recruiting
Auckland Hospital - Greenlane Clinical Centre - National Women's Hospital
Auckland
Maria Pilar Aparisi Gómez, MD
About this study
Official title: Comparative Evaluation of Phantomless Calibration Methods to Quantify Bone Mineral Density for Opportunistic Analysis of CT Scans
Osteoporosis is a systemic disease characterized by a reduction in bone mineral density (BMD) and qualitative alteration of the skeleton, resulting in increased bone fragility and fracture risk. The epidemiological impact of osteoporosis is extremely high. Proper diagnosis and clinical management of osteoporosis are critical to reducing the incidence of fragility fractures and preventing their complications. The diagnosis is generally confirmed by instrumental analysis of bone mineral density. The standard method is X-ray bone densitometry (DXA), which allows diagnosis based on criteria defined by the World Health Organization (WHO) by virtue of the T-score. DXA is a relatively quick and inexpensive examination with low exposure to ionizing radiation. However, this method has limitations in detecting fracture risk, and in addition, not all patients are properly referred for DXA services, which, among other things, require specific criteria to be reimbursed by the National Health System. Currently, computed tomography (CT) scanning is the most widely used three-dimensional diagnostic modality in clinical practice, and the number of investigations performed in high-income countries is continuously growing. Quantitative assessment of bone mineral density by CT is possible by proper calibration of the machine for the purpose of converting the CT numbers (or Hounsfield units) measured by the scanner into BMD units.
- Conditions
- Osteoporosis
- Being tested
- Phantom
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhantomOther
The patients will be simultaneously scanned with a QCT phantom
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Patients that require a TC scan. Receives: Other: Phantom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of different internal calibration methods
Compare the different methods of internal or phantomless calibration described in the literature with synchronous and asynchronous calibration in a population of patients undergoing CT scans that include the lumbar spine to assess their feasibility.
Measured: At baseline (Day 0)
Secondary outcomes (2)
Definition of performance of internal calibration methods
Define the performance of various internal or phantomless calibration methods for the purpose of identifying the most appropriate and reliable technique.
Measured: At baseline (Day 0)
Optimization of existing internal calibration methods
Optimize existing internal calibration methods, and eventually define a new phantomless targeted calibration protocol based on the results of the study.
Measured: Through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start6 Jun 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Collaborators
- Auckland Hospital - Greenlane Clinical Centre - National Women's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454617
- Sponsor's protocol ID
- Calibr-I
- Acronym
- Calibr-Ì
- Status last verified
- Jun 2025
- First submitted
- 6 Jun 2024
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rossini M, Adami S, Bertoldo F, Diacinti D, Gatti D, Giannini S, Giusti A, Malavolta N, Minisola S, Osella G, Pedrazzoni M, Sinigaglia L, Viapiana O, Isaia GC. Guidelines for the diagnosis, prevention and management of osteoporosis. Reumatismo. 2016 Jun 23;68(1):1-39. doi: 10.4081/reumatismo.2016.870.
PubMed 27339372Willers C, Norton N, Harvey NC, Jacobson T, Johansson H, Lorentzon M, McCloskey EV, Borgstrom F, Kanis JA; SCOPE review panel of the IOF. Osteoporosis in Europe: a compendium of country-specific reports. Arch Osteoporos. 2022 Jan 26;17(1):23. doi: 10.1007/s11657-021-00969-8.
PubMed 35079919Engelke K, Lang T, Khosla S, Qin L, Zysset P, Leslie WD, Shepherd JA, Shousboe JT. Clinical Use of Quantitative Computed Tomography-Based Advanced Techniques in the Management of Osteoporosis in Adults: the 2015 ISCD Official Positions-Part III. J Clin Densitom. 2015 Jul-Sep;18(3):393-407. doi: 10.1016/j.jocd.2015.06.010.
PubMed 26277853Michalski AS, Besler BA, Michalak GJ, Boyd SK. CT-based internal density calibration for opportunistic skeletal assessment using abdominal CT scans. Med Eng Phys. 2020 Apr;78:55-63. doi: 10.1016/j.medengphy.2020.01.009. Epub 2020 Feb 12.
PubMed 32059948
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Phantomless Calibration Methods to Quantify Bone Mineral Density for Opportunistic Analysis of CT Scans
- ClinicalTrials.gov ID
- NCT06454617
- Acronym / sponsor ID
- Calibr-Ì / Calibr-I
- Conditions
- Osteoporosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Collaborators
- Auckland Hospital - Greenlane Clinical Centre - National Women's Hospital
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 Jun 2024 (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.
Osteoporosis is a systemic disease characterized by a reduction in bone mineral density (BMD) and qualitative alteration of the skeleton, resulting in increased bone fragility and fracture risk. The epidemiological impact of osteoporosis is extremely high. Proper diagnosis and clinical management of osteoporosis are critical to reducing the incidence of fragility fractures and preventing their complications. The diagnosis is generally confirmed by instrumental analysis of bone mineral density. The standard method is X-ray bone densitometry (DXA), which allows diagnosis based on criteria defined by the World Health Organization (WHO) by virtue of the T-score. DXA is a relatively quick and inexpensive examination with low exposure to ionizing radiation. However, this method has limitations in detecting fracture risk, and in addition, not all patients are properly referred for DXA services, which, among other things, require specific criteria to be reimbursed by the National Health System. Currently, computed tomography (CT) scanning is the most widely used three-dimensional diagnostic modality in clinical practice, and the number of investigations performed in high-income countries is continuously growing. Quantitative assessment of bone mineral density by CT is possible by proper calibration of the machine for the purpose of converting the CT numbers (or Hounsfield units) measured by the scanner into BMD units.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Other: PhantomPatients that require a TC scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will involve a population of patients undergoing CT scans including the lumbar spine at the Diagnostic and Interventional Radiology Unit of each participating center. In CT scans requiring the administration of contrast medium, only the non-contrast-enhanced images will be considered.
Key inclusion criteria (5 listed)
- Both sexes.
- All ethnicities.
- Age equal or above 18 years.
- Any clinical indication (no specific pathology is required) for a CT scan of the lumbosacral spine or abdomen in which the entire lumbar spine (L1 to L5), paravertebral muscles, abdominal aorta, and subcutaneous adipose tissue are visible.
- Ability to give informed consent.
Key exclusion criteria (6 listed)
- General contraindications to CT examination, including pregnancy or body weight/size exceeding scanner limits.
- Severe degenerative manifestations of the lumbosacral spine.
- Severe scoliosis of the lumbosacral spine.
- Surgical hardware that prevents adequate CT scanning.
- Oncologic pathology in progress or in recent history.
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 |
|---|---|---|
| PhantomThe patients will be simultaneously scanned with a QCT phantom | Other | Experimental |
Primary outcome
Comparison of different internal calibration methods
Time frame: At baseline (Day 0)
Compare the different methods of internal or phantomless calibration described in the literature with synchronous and asynchronous calibration in a population of patients undergoing CT scans that include the lumbar spine to assess their feasibility.
2 secondary outcomes
Definition of performance of internal calibration methods
Time frame: At baseline (Day 0)
Optimization of existing internal calibration methods
Time frame: Through study completion, up to 2 years
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 10 Jun 2025.
- Results publication: PubMed 27339372Rossini M, Adami S, Bertoldo F, Diacinti D, Gatti D, Giannini S, Giusti A, Malavolta N, Minisola S, Osella G, Pedrazzoni M, Sinigaglia L, Viapiana O, Isaia GC. Guidelines for the diagnosis, prevention and management of osteoporosis. Reumatismo. 2016 Jun 23;68(1):1-39. doi: 10.4081/reumatismo.2016.870.
- Results publication: PubMed 35079919Willers C, Norton N, Harvey NC, Jacobson T, Johansson H, Lorentzon M, McCloskey EV, Borgstrom F, Kanis JA; SCOPE review panel of the IOF. Osteoporosis in Europe: a compendium of country-specific reports. Arch Osteoporos. 2022 Jan 26;17(1):23. doi: 10.1007/s11657-021-00969-8.
- Results publication: PubMed 26277853Engelke K, Lang T, Khosla S, Qin L, Zysset P, Leslie WD, Shepherd JA, Shousboe JT. Clinical Use of Quantitative Computed Tomography-Based Advanced Techniques in the Management of Osteoporosis in Adults: the 2015 ISCD Official Positions-Part III. J Clin Densitom. 2015 Jul-Sep;18(3):393-407. doi: 10.1016/j.jocd.2015.06.010.
- Results publication: PubMed 32059948Michalski AS, Besler BA, Michalak GJ, Boyd SK. CT-based internal density calibration for opportunistic skeletal assessment using abdominal CT scans. Med Eng Phys. 2020 Apr;78:55-63. doi: 10.1016/j.medengphy.2020.01.009. Epub 2020 Feb 12.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Istituto Ortopedico Rizzoli at 2 sites in 2 countries.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, New Zealand. 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?
Contact Alberto Bazzocchi, MD (051636 ext. 6028, alberto.bazzocchi@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of different internal calibration methods (time frame: At baseline (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06454617, which also lists 4 linked publications.
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 10 Jun 2025.