OsteoporosisNCT04413448
Performance of CT Parameters Compared to Bone Mineral Density to Detect Bone Fragility in Rheumatoid Arthritis
An observational study of Osteoporosis and Rheumatoid Arthritis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Objective: To evaluate the performance of CT parameters (SBAC-L1 and fractal analysis) compared to BMD (gold standard) to detect vertebral fractures in rheumatoid arthritis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis, Rheumatoid Arthritis, Vertebral Fracture
- How many people
- 260 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 1 Jan 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rheumatoid arthritis patients followed from 2009 to 2019 in Nancy University hospital who met the 2010 ACR/EULAR criteria for RA and examined using thoraco-abdomino-pelvic CT (TAP-CT) and BMD (spine, hip) within a period of up to 2 years were included.
Who may be able to join
- Rheumatoid arthritis patients followed from 2009 to 2019 in Nancy University hospital who met the 2010 ACR/EULAR criteria for RA
- Thoraco-abdomino-pelvic CT (TAP-CT) and BMD (spine, hip) within a period of up to 2 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital Nancy
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511
About this study
Official title: Performance of CT Parameters (SBAC-L1, Fractal Analysis) Compared to BMD (Gold Standard) to Detect Vertebral Fractures in rheumatoïd Arthritis
Objective: To evaluate the performance of CT parameters (SBAC-L1 and fractal analysis) compared to BMD (gold standard) to detect vertebral fractures in rheumatoid arthritis
Read the detailed description
To evaluate the performance of scanographic bone attenuation coefficient of the first lumbar vertebra (SBAC-L1) and fractal analysis, markers of bone fragility on computed tomography (CT), compared to bone mineral density (BMD) to detect vertebral fractures in rheumatoid arthritis (RA).
Patient and methods: Rheumatoid arthritis patients followed from 2009 to 2019 in Nancy University hospital who met the 2010 ACR/EULAR criteria for RA and examined using thoraco-abdomino-pelvic CT (TAP-CT) and BMD (spine, hip) within a period of up to 2 years were included. Scanographic bone attenuation coefficient and fractal dimension of the first lumbar vertebra (SBAC-L1, FD-L1) were measured on CT. Vertebral fractures of the thoracolumbar spine were evaluated on CT according to an adaptation of Genant's scoring method.
Demographic characteristics (age, sex, smoking), clinical data (disease duration, DAS-28), biological data (C-reactive protein (CRP), RF, ACPA) and treatments (n proton pump inhibitor, corticosteroid, TNF-inhibitors (TNFi) and others biologics, calcium, vitamin D, antiresorptive agents) were collected from the complete medical record. Univariate and multivariate analysis were performed to determine if these variables were associated or not with bone fragility (vertebral fracture, SBAC-L1, FD-L1).
We evaluated the performance and diagnostic complementarity as well as optimal diagnostic thresholds of SBAC-L1, FD-L1 and BMD (gold standard) to detect vertebral fractures in these patients at risk of osteoporosis.
Intra and inter-readers reproducibilities of the scanographic screening methods (SBAC-L1, FD-L1) were also studied.
- Conditions
- Osteoporosis, Rheumatoid Arthritis, Vertebral Fracture
- Medical subject headings
- Osteoporosis, Arthritis, Rheumatoid, Spinal Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of SBAC-L1 to detect the presence of vertebral fracture on CT
Measured: 4 months
Performance of FD-L1 to detect the presence of vertebral fracture on CT
Measured: 4 months
Secondary outcomes (3)
ROC curves to determine fracture thresholds to detect vertebral fractures on SBAC-L1( in Hounsfield Unit)
Measured: 1 month
Correlation between demographic , clinical, biologic and treatments and the presence of bone fragility (vertebral fracture, SBAC-L1, FD-L1)
Correlation between demographic (age, sexe, osteoporotic factors), clinical (disease duration, disease activity) biologic (CRP, ACPA, Rheumatoid Factor) and treatments (corticosteroids, biologic, DMARDs, anti-osteoporotic) and the presence of bone fragility (vertebral fracture, SBAC-L1, FD-L1)
Measured: 4 month
ROC curves to determine fracture thresholds to detect vertebral fractures on FD-L1
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jan 2020
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
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
- Retrospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien Loeuille, MD-PhD, Principal investigator, +33662436967
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413448
- Sponsor's protocol ID
- 2020PI083
- Status last verified
- May 2020
- First submitted
- 7 May 2020
- Last updated
- 4 Jun 2020
- 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 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of CT Parameters (SBAC-L1, Fractal Analysis) Compared to BMD (Gold Standard) to Detect Vertebral Fractures in rheumatoïd Arthritis
- ClinicalTrials.gov ID
- NCT04413448
- Acronym / sponsor ID
- 2020PI083
- Conditions
- Osteoporosis, Rheumatoid Arthritis, Vertebral Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 4 Jun 2020 (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.
Objective: To evaluate the performance of CT parameters (SBAC-L1 and fractal analysis) compared to BMD (gold standard) to detect vertebral fractures in rheumatoid arthritis
Detailed description
To evaluate the performance of scanographic bone attenuation coefficient of the first lumbar vertebra (SBAC-L1) and fractal analysis, markers of bone fragility on computed tomography (CT), compared to bone mineral density (BMD) to detect vertebral fractures in rheumatoid arthritis (RA).
Patient and methods: Rheumatoid arthritis patients followed from 2009 to 2019 in Nancy University hospital who met the 2010 ACR/EULAR criteria for RA and examined using thoraco-abdomino-pelvic CT (TAP-CT) and BMD (spine, hip) within a period of up to 2 years were included. Scanographic bone attenuation coefficient and fractal dimension of the first lumbar vertebra (SBAC-L1, FD-L1) were measured on CT. Vertebral fractures of the thoracolumbar spine were evaluated on CT according to an adaptation of Genant's scoring method.
Demographic characteristics (age, sex, smoking), clinical data (disease duration, DAS-28), biological data (C-reactive protein (CRP), RF, ACPA) and treatments (n proton pump inhibitor, corticosteroid, TNF-inhibitors (TNFi) and others biologics, calcium, vitamin D, antiresorptive agents) were collected from the complete medical record. Univariate and multivariate analysis were performed to determine if these variables were associated or not with bone fragility (vertebral fracture, SBAC-L1, FD-L1).
We evaluated the performance and diagnostic complementarity as well as optimal diagnostic thresholds of SBAC-L1, FD-L1 and BMD (gold standard) to detect vertebral fractures in these patients at risk of osteoporosis.
Intra and inter-readers reproducibilities of the scanographic screening methods (SBAC-L1, FD-L1) were also studied.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rheumatoid arthritis patients followed from 2009 to 2019 in Nancy University hospital who met the 2010 ACR/EULAR criteria for RA and examined using thoraco-abdomino-pelvic CT (TAP-CT) and BMD (spine, hip) within a period of up to 2 years were included.
Key inclusion criteria (2 listed)
- Rheumatoid arthritis patients followed from 2009 to 2019 in Nancy University hospital who met the 2010 ACR/EULAR criteria for RA
- Thoraco-abdomino-pelvic CT (TAP-CT) and BMD (spine, hip) within a period of up to 2 years
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Performance of SBAC-L1 to detect the presence of vertebral fracture on CT
Time frame: 4 months
Performance of FD-L1 to detect the presence of vertebral fracture on CT
Time frame: 4 months
3 secondary outcomes
ROC curves to determine fracture thresholds to detect vertebral fractures on SBAC-L1( in Hounsfield Unit)
Time frame: 1 month
Correlation between demographic , clinical, biologic and treatments and the presence of bone fragility (vertebral fracture, SBAC-L1, FD-L1)
Time frame: 4 month
ROC curves to determine fracture thresholds to detect vertebral fractures on FD-L1
Time frame: 1 month
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 4 Jun 2020.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- 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.
Damien Loeuille, MD-PhD principal investigator
+33662436967
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 Rheumatoid Arthritis, run by Central Hospital, Nancy, France 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 2 inclusion and 0 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 4 Jun 2020. 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?
Performance of SBAC-L1 to detect the presence of vertebral fracture on CT (time frame: 4 months). 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 4 Jun 2020.