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Evaluation of the prevalence, incidence and progression of bone erosions in rheumatoid arthritis (RA) by high-resolution peripheral quantitative computer tomography (HRpQCT) compared to standard imaging techniques

Evaluation of the prevalence, incidence and progression of bone erosions in rheumatoid arthritis (RA) by high-resolution peripheral quantitative computer tomography (HRpQCT) compared to standard imaging techniques - Evaluation of bone erosions in RA with HRpQCT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41257
Enrollment
90
Registered
2012-12-05
Start date
2013-03-06
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

rheumatoid arthritis (RA)

Interventions

Blood 2x 4ml EDTA and 2x 10 ml serum. HRpQCT and radiography, in total 80 microSv for RA patients and 68 microSv for healthy controls and females with handosteoarthritis .

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients who are diagnosed with RA, based on the American College of Rheumatology criteria Patients who understand the conditions of the study and are willing and able to comply with the scheduled evaluations. Patients who signed the Ethics Committee approved specific Informed Consent Form prior to inclusion.

Exclusion criteria

Exclusion criteria: 1. Patients who underwent surgery of the hand or fingers or who are expected to need surgery of the hand in due course 2. Patients with malignancy in the last 12 months 3. Patients with a neuromuscular or neurosensory deficit which would limit the ability to assess the affected joint during the HR-pQCT evaluation. 4. Patients with known systemic or metabolic disorders leading to progressive bone deterioration such as: a. Primary hyperthyroidism b. Primary hyperparathyroidism c. Chronic kidney disease with eGFR

Design outcomes

Primary

MeasureTime frame
The primary outcome of the study is 1/ cross-sectionally - the prevalence of bone erosions and 2/ longitudinally - the progression of bone erosions in the 2nd and 3rd proximal interphalangeal (PIP) joints and metacarpophalangeal (MCP) joints of the hands bilaterally in patients with RA, and healthy controls only the dominant hand 2nd and 3rd PIP, MCP joints and including the 2nd and 3rd distal interphalangeal (DIP) joints, by using the HRpQCT (Total of 800 RA + 480 healthy control joints in the study + 120 joints of females with handosteoarthritis).

Secondary

MeasureTime frame
Secondary outcomes are the comparison of the number of joints with erosions detected by HRpQCT with 1/ the number of joints with erosions detected by X-rays, MRI and US and 2/ the number of joints with osteitis by MRI; exploring possibilities to quantify the 3-D joint space volume occupied by cartilage; and the correlation between the prevalence and progression of erosions with serum bone turnover markers.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)