Performance of CT Parameters Compared to Bone Mineral Density to Detect Bone Fragility in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Performance of CT Parameters (SBAC-L1, Fractal Analysis) Compared to BMD (Gold Standard) to Detect Vertebral Fractures in rheumatoïd Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04413448
• Other study ID #: 2020PI083
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: January 1, 2020

Study information

• Verified date: May 2020
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteoporosis
• Rheumatoid Arthritis
• Spinal Fractures
• Vertebral Fracture

Locations

Country	Name	City	State
France	University Hospital Nancy	Vandœuvre-lès-Nancy	Meurthe-et-Moselle

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of SBAC-L1 to detect the presence of vertebral fracture on CT		4 months
Primary	Performance of FD-L1 to detect the presence of vertebral fracture on CT		4 months
Secondary	ROC curves to determine fracture thresholds to detect vertebral fractures on SBAC-L1( in Hounsfield Unit)		1 month
Secondary	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)	4 month
Secondary	ROC curves to determine fracture thresholds to detect vertebral fractures on FD-L1		1 month

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