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Bone Erosions in Rheumatoid Arthritis - Characterization Evaluated by Imaging and Histology

Bone Erosions in Rheumatoid Arthritis - Characterization Evaluated by Imaging and Histology

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04645381
Acronym
BERA
Enrollment
9
Registered
2020-11-27
Start date
2020-11-01
Completion date
2035-11-01
Last updated
2026-05-04

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

Conditions

Arthritis, Rheumatoid

Keywords

Rheumatoid Arthritis, High-resolution peripheral quantitative computed tomography, Radiography, Micro computed tomography, Histology

Brief summary

The aim of this study is to describe macro- and micro anatomical structures, including investigating vessels running in osseous pores in finger joints from participants with rheumatoid arthritis (RA) using histology and different imaging modalities. The perspectives are to increase understanding of the macro- and micro anatomic basis for bone erosions in RA, and possibly to provide new insights to the monitoring of patients with RA.

Detailed description

This study is a descriptive, cross-sectional pilot study. The trial subjects will have their hands imaged by conventional radiography. The 2nd and 3rd digit metacarpophalangeal (MCP) joint will be scanned by high-resolution peripheral quantitative computed tomography (HR-pQCT). Patients with RA (n = 10) will be included and bone samples from MCP joints analyzed using microcomputed tomography (µCT) and histology. ELIGIBILITY CRITERIA Inclusion criteria: * Age \> 18 years. * Participants diagnosed with RA according to the ACR/EULAR (2010) classification criteria or American Rheumatism Association 1987 revised criteria for the patients who were diagnosed before 2010. * Indication for prosthesis surgery with total joint replacement of the MCP joint according to the clinical procedure (often radiological signs of osteoarthrosis (OA) in the MCP joint, joint pain, angular deformity and/or impairment of daily functions).

Interventions

None listed

Sponsors

University of Aarhus
Lead SponsorOTHER
Aarhus University Hospital
CollaboratorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

RA Participants: Inclusion Criteria: * Age \> 18 years * Participants diagnosed with RA according to the ACR/EULAR (2010) classification criteria or American Rheumatism Association 1987 revised criteria for the patients who were diagnosed before 2010. * Indication for prosthesis surgery with total joint replacement of the MCP joint according to the clinical procedure (often radiological signs of OA in the MCP joint, joint pain, angular deformity and/or impairment of daily functions).

Exclusion criteria

* Unable to give written informed consent. * Active malignant disease, hypercalcemia, poor kidney function (estimated glomerular filtration rate \< 35 mL/min), untreated hypo-/hyperthyroidism, pregnancy or wish thereof, previously fracture/dislocation of the investigated joint or metal prosthesis in joints of the investigated hand. Bone sample will be excluded from analysis, if the following is present: \- Bone not adequate for analysis (fractured bone samples).

Design outcomes

Primary

MeasureTime frameDescription
Transcortical vessels and pores.within 24 weeks after inclusionTo identify and describe transcortical vessels and pores at the bare area in MCP joints from RA patients and describe the location, number, and compare intra- and extra-articularly by histology, μCT, and HR-pQCT.

Secondary

MeasureTime frameDescription
The bare areawithin 24 weeks after inclusionTo identify and describe the bare area in MCP joints from RA patients macroscopically, with imaging (HR-pQCT, conventional X-ray, μCT), and histology.
Bone erosionswithin 24 weeks after inclusionTo identify bone erosions by conventional X-ray, μCT, and HR-pQCT and assess inflammatory infiltrates using histology in RA patients.

Countries

Denmark

Contacts

STUDY_DIRECTOREllen-Margrethe Hauge, Professor

Aarhus University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026