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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04413448

Enrollment

260

Registered

2020-06-04

Start date

2020-01-01

Completion date

2020-01-01

Last updated

2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Rheumatoid Arthritis, Vertebral Fracture

Brief 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

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Performance of SBAC-L1 to detect the presence of vertebral fracture on CT	4 months
Performance of FD-L1 to detect the presence of vertebral fracture on CT	4 months

Secondary

Measure	Time frame	Description
ROC curves to determine fracture thresholds to detect vertebral fractures on SBAC-L1( in Hounsfield Unit)	1 month	—
Correlation between demographic , clinical, biologic and treatments and the presence of bone fragility (vertebral fracture, SBAC-L1, FD-L1)	4 month	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)
ROC curves to determine fracture thresholds to detect vertebral fractures on FD-L1	1 month	—

Countries

France

Outcome results