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Enrolling by invitation Observational

Progression of Bone Erosions in Rheumatoid Arthritis Assessed by HR-pQCT and Conventional X-ray

NCT03429426 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2018-02-15
Last updated
2021-01-13

Condition(s) studied

Arthritis, Rheumatoid

Study summary

Today, regular X-ray examination is not sufficiently sensitive for detecting progression of bone destruction in rheumatoid arthritis, but a new type of high-resolution CT scanner, the High-Resolution peripheral Quantitative Computed Tomography (HR-pQCT) can detect very early and minor joint injuries.

The purpose of this study is to use HR-pQCT techniques to look at the damage and disease activity progression in the hand and wrist joints of patients with rheumatoid arthritis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Rheumatoid arthritis patients Inclusion criteria * Patients (\> 18 years) with rheumatoid arthritis ≥5 years according to the ACR/EULAR (2010) classification criteria or American Rheumatism Association 1987 revised criteria for the patients who were diagnosed before 2010. * Patients who are receiving treatment on an outpatient basis. * Ability and willingness to give written informed consent and to meet the requirements of the trial protocol. Exclusion criteria * Patients who have previously suffered trauma in the form of fracture or luxation of the hand are excluded. * Evidence of active malignant disease. * Hypo- or hyperthyroidism. * Hypocalcaemia. * Impaired renal function (eGFR \<35ml/min). * Pregnancy. Pre-rheumatoid arthritis patients Inclusion criteria * Age over 18 years. * Anti-CCP 3 times the upper limit of the reference interval. * Arthralgia. * Ability and willingness to give written informed consent and to meet the requirements of the trial protocol. Exclusion criteria * Pregnancy. * Swelling of joints. Verified by clinical ultrasound. * Patients who have previously suffered trauma in the form of fracture or luxation of the hand are excluded. * Evidence of malignant disease. * Hypo- or hyperthyroidism. * Hypocalcaemia. Healthy subjects Inclusion criteria * Age over 18 years. * No joint complaints. * Ability and willingness to give written informed consent and to meet the requirements of the trial protocol. Exclusion criteria * Patients who have previously suffered trauma in the form of fracture or luxation of the hand are excluded. * Evidence of malignant disease. * Hypo- or hyperthyroidism. * Hypocalcaemia. * Impaired renal function (eGFR \<35ml/min). * Earlier or present rheumatological disease or bone metabolic disease. * Positive anti-CCP. * Pregnancy.

Primary outcome measure(s)

  • Erosion changes by HR-pQCT — One year
    Changes in bone erosions volume in mm3 by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
  • Volumetric bone mineral density(vBMD) changes by HR-pQCT — One year
    Changes in volumetric bone mineral density(vBMD) in mgHA/cm3 by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
  • Erosion changes by HR-pQCT — One year
    Changes in bone erosions width in mm by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
  • Erosion changes by HR-pQCT — One year
    Changes in bone erosions depth in mm by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.

Trial sites (1)

FacilityCityRegionStatus
Department of Rheumatology, Aarhus University Hospital Aarhus Denmark

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03429426 on ClinicalTrials.gov ↗ ← All trials in Denmark