Bone Fracture3D DXA SPINENCT03638674
Evaluation of Agreement Between CT Scan and 3D-DXA Measurements on the Lombar Spine
A study testing DXA + CT in people with Bone Fracture, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Dual-energy X-ray Absorptiometry is frequently used to measure bone mineral density. A new medical device, Box 3D DXA, creates a 3D image using a statistics reconstruction model developed on the femur. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Fracture
- What is being tested?
- DXA + CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 26 Feb 2019to 20 Aug 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient is at least 18 years old
- The patient has been referred by a doctor for a PET/CT (Positron Emission Tomography-Computed Tomography) scan or a SPECT (Single Photon Emission Computed Tomography) scan in the Nuclear Medicine and Medical Biophysics Department of Nimes hospital or a bone scan including a SPECT/CT (single photon emission computed tomography coupled with a CT scan)
Who cannot join
- The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patients is under judicial protection or state guardianship
- The patient is pregnant or breast feeding
- The subject has a observably serious scoliosis
Show all 11Show fewer
- Subject has previously had spinal or hip surgery
- Subject weighs more than 200kg and/or is more than 2 meters tall by 5+65cm wide and 70cm diameter
- Patient uses an insulin pump or wears an insulin or morphine tubing or any attenuating equipment affecting the hips or lumbar spine
- Subject has already had an X-ray exam using a contrast product such as barium in the 7 days preceding the visit
- Subject having undergone γ radiation exam in the 15 days preceding the visit
Trial locations and contacts
1 site in 1 country.
About this study
Dual-energy X-ray Absorptiometry is frequently used to measure bone mineral density. A new medical device, Box 3D DXA, creates a 3D image using a statistics reconstruction model developed on the femur. This new imaging technique does not require additional irradiation and ought to improve bone measures as well as incorporating densitometric parameters into the diagnosis. This study will test the reconstruction of the 3D image from lombar spine measurements and compare accuracy against measurements made using CT scan.
- Conditions
- Bone Fracture
- Being tested
- DXA + CT
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXA + CTOther
Two dual-energy X-ray scans + CT scan
| Study group | Role | What they receive |
|---|---|---|
| 2nd lumbar spine acquisition in same position | Active comparator | spine and hip STRATOS DR + 2nd lumbar spine acquisition in same position (with template) Receives: Other: DXA + CT |
| 2nd lumbar spine acquisition | Active comparator | spine and hip STRATOS DR + 2nd lumbar spine acquisition (no template) Receives: Other: DXA + CT |
| 2nd hip acquisition in same position | Active comparator | spine and hip STRATOS DR + 2nd hip acquisition in same position (with template) Receives: Other: DXA + CT |
| 2nd hip acquisition | Active comparator | spine and hip STRATOS DR + 2nd hip acquisition (without template) Receives: Other: DXA + CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance in lombar spine measurements between box 3D-DXA (index test) and CT scan (reference test)
Lin's concordance coefficient
Measured: Day 0
Concordance in lombar spine measurements between box 3D-DXA (index test) and CT scan (reference test)
Bland Altman plot
Measured: Day 0
Secondary outcomes (6)
Reproducibility of the 3D-DXA Spine algorithm for lombar spine measurements
2 acquisitions under the same conditions. Using root-mean-square coefficient of variation to calculate the Least Significant Change
Measured: Day 0
Robustness of 3D-DXA Spine measurement for lombar spine measurements
2 acquisitions under the same conditions. Using interquartile range as a measure of dispersion of the variable
Measured: Day 0
Concordance in femur measurements between box 3D-DXA (index test) and CT scan (reference test)
Lin's concordance coefficient
Measured: Day 0
Concordance in femur measurements between box 3D-DXA (index test) and CT scan (reference test)
Bland Altman plot
Measured: Day 0
Reproducibility of the 3D-DXA Femur algorithm for femur measurements
2 acquisitions under the same conditions. Using root-mean-square coefficient of variation to calculate the Least Significant Change
Measured: Day 0
Robustness of 3D-DXA Femur measurement for femur measurements
2 acquisitions under the same conditions. Using interquartile range as a measure of dispersion of the variable
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start26 Feb 2019
- Primary completion20 Aug 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone FractureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- DMS Apelem
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638674
- Sponsor's protocol ID
- LOCAL/2016/VB-01
- Acronym
- 3D DXA SPINE
- Status last verified
- Jun 2026
- First submitted
- 2 Aug 2018
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Agreement Between CT Scan and 3D-DXA Measurements on the Lombar Spine
- ClinicalTrials.gov ID
- NCT03638674
- Acronym / sponsor ID
- 3D DXA SPINE / LOCAL/2016/VB-01
- Conditions
- Bone Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- DMS Apelem
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 20 Aug 2018 (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.
Dual-energy X-ray Absorptiometry is frequently used to measure bone mineral density. A new medical device, Box 3D DXA, creates a 3D image using a statistics reconstruction model developed on the femur. This new imaging technique does not require additional irradiation and ought to improve bone measures as well as incorporating densitometric parameters into the diagnosis. This study will test the reconstruction of the 3D image from lombar spine measurements and compare accuracy against measurements made using CT scan.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2nd lumbar spine acquisition in same position | Active comparator | Other: DXA + CTspine and hip STRATOS DR + 2nd lumbar spine acquisition in same position (with template) |
| 2nd lumbar spine acquisition | Active comparator | Other: DXA + CTspine and hip STRATOS DR + 2nd lumbar spine acquisition (no template) |
| 2nd hip acquisition in same position | Active comparator | Other: DXA + CTspine and hip STRATOS DR + 2nd hip acquisition in same position (with template) |
| 2nd hip acquisition | Active comparator | Other: DXA + CTspine and hip STRATOS DR + 2nd hip acquisition (without template) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient is at least 18 years old
- The patient has been referred by a doctor for a PET/CT (Positron Emission Tomography-Computed Tomography) scan or a SPECT (Single Photon Emission Computed Tomography) scan in the Nuclear Medicine and Medical Biophysics Department of Nimes hospital or a bone scan including a SPECT/CT (single photon emission computed tomography coupled with a CT scan)
Key exclusion criteria (11 listed)
- The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patients is under judicial protection or state guardianship
- The patient is pregnant or breast feeding
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 + CTTwo dual-energy X-ray scans + CT scan | Other | 2nd hip acquisition, 2nd hip acquisition in same position, 2nd lumbar spine acquisition, 2nd lumbar spine acquisition in same position |
Primary outcome
Concordance in lombar spine measurements between box 3D-DXA (index test) and CT scan (reference test)
Time frame: Day 0
Lin's concordance coefficient
Concordance in lombar spine measurements between box 3D-DXA (index test) and CT scan (reference test)
Time frame: Day 0
Bland Altman plot
6 secondary outcomes
Reproducibility of the 3D-DXA Spine algorithm for lombar spine measurements
Time frame: Day 0
Robustness of 3D-DXA Spine measurement for lombar spine measurements
Time frame: Day 0
Concordance in femur measurements between box 3D-DXA (index test) and CT scan (reference test)
Time frame: Day 0
Concordance in femur measurements between box 3D-DXA (index test) and CT scan (reference test)
Time frame: Day 0
Reproducibility of the 3D-DXA Femur algorithm for femur measurements
Time frame: Day 0
Robustness of 3D-DXA Femur measurement for femur measurements
Time frame: Day 0
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 16 Jun 2026.
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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?
A study testing DXA + CT in people with Bone Fracture, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 11 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 16 Jun 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 France. 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?
Concordance in lombar spine measurements between box 3D-DXA (index test) and CT scan (reference test) (time frame: Day 0). The study lists 2 primary outcomes in all. 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 16 Jun 2026.