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

Completed

Conditions: rheumatoid arthritis (RA)
10023213

Registration Number: NL-OMON41257

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

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

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< 30 ml/min.
d. Sarcoidosis
5. Patients with other rheumatic disorders involving the joints, such as osteoarthritis
6. Patients who are pregnant or willing to become pregnant or are breastfeeding.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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