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Enrolling by invitation NCT03429426

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

— Observational Arthritis, Rheumatoid

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Arthritis, Rheumatoid. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Observational Study of Bone Erosion Determination and Progression in Rheumatoid Arthritis Assessed by HR-pQCT and Conventional X-ray

Overview

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.

Detailed description

The design of the trial is an observational study with three distinct groups. At the start of the trial period and at one-year of follow-up, the trial subject will have their hand X-rayed by conventional radiography, and their metacarpophalangeal (MCP) joint and wrist scanned by HR-pQCT-Imaging. The 28-joint Disease Activity Score(DAS28-CRP), Health Assessment Questionnaire (HAQ), Visual analogue scale(VAS)-score for pain, fatigue and quality of life are performed to investigate the correlation between radiographic changes and disease activity. Blood samples are collected to investigate serological markers of bone metabolism and inflammation and the radiographic changes. The following groups are investigated:

* Rheumatoid Arthritis(RA): Patients with RA ≥5 years according to the ACR/EULAR 2010 classification criteria or the American Rheumatism Association 1987 revised criteria are recruited from the outpatient clinic at the Department of Rheumatology, Aarhus University Hospital. Treatment will be adjusted according to the patient's need and according to national guidelines. (n=450) * Pre-RA patients: Patients with pre-RA, (joint pain, but no swelling and Anti-CCP 3 times above the upper limit) are recruited from the outpatient clinic at the Department of Rheumatology, Aarhus University Hospital. (n=75) * Healthy subjects: Healthy age- and sex-matched Individuals are recruited, as a control group, by posting at libraries in Aarhus, Aarhus University, Aarhus University Hospital and postings on the websites www.forsøgsperson.dk and www.Sundhed.dk. (N=100)

Primary outcome measures

  • Erosion changes by HR-pQCT [Time frame: One year]
  • Volumetric bone mineral density(vBMD) changes by HR-pQCT [Time frame: One year]
  • Erosion changes by HR-pQCT [Time frame: One year]
  • Erosion changes by HR-pQCT [Time frame: One year]
Secondary outcome measures (12)
  • Radiographic erosion score [Time frame: One year]
  • CTX [Time frame: one year]
  • P1NP [Time frame: one year]
  • BAP [Time frame: one year]
  • TNF-α [Time frame: one year]
  • RANK-L [Time frame: one year]
  • OPG [Time frame: one year]
  • BGLAP [Time frame: one year]
  • SCL [Time frame: one year]
  • Dkk-1 [Time frame: one year]
  • IL-1 [Time frame: one year]
  • IL-6 [Time frame: one year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Department of Rheumatology, Aarhus University Hospital — Aarhus

Publications

  • Therkildsen J, Klose-Jensen R, Langdahl B, Bruel A, Thomsen JS, Moger C, Stilling M, Keller KK, Hauge EM. Mapping the bare area and transcortical pores in finger joints: co-location with bone erosions in rheumatoid arthritis. RMD Open. 2026 Jan 22;12(1):e006371. doi: 10.1136/rmdopen-2025-006371. PMID 41571324
  • Therkildsen J, Klose-Jensen R, Hanel M, Langdahl BL, Thomsen JS, Manske SL, Keller KK, Hauge EM. Detecting new erosions in rheumatoid arthritis over one year - Radiography and high-resolution computed tomography of finger joints. Joint Bone Spine. 2025 Jan;92(1):105812. doi: 10.1016/j.jbspin.2024.105812. Epub 2024 Nov 14. PMID 39547428
  • Therkildsen J, Klose-Jensen R, Hanel M, Langdahl BL, Thygesen J, Thomsen JS, Manske SL, Keller KK, Hauge EM. Erosive progression by high-resolution peripheral quantitative computed tomography and conventional radiography in rheumatoid arthritis. Rheumatology (Oxford). 2025 Mar 1;64(3):1092-1101. doi: 10.1093/rheumatology/keae281. PMID 38749001
  • Klose-Jensen R, Therkildsen J, Blavnsfeldt AG, Langdahl BL, Zejden A, Thygesen J, Keller KK, Hauge EM. Diagnostic accuracy of high-resolution peripheral quantitative computed tomography and X-ray for classifying erosive rheumatoid arthritis. Rheumatology (Oxford). 2022 Mar 2;61(3):963-973. doi: 10.1093/rheumatology/keab446. PMID 34015091

Identifiers

NCT: NCT03429426 · RACTX

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗