- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06038292
The Relationship Between Rheumatoid Arthritis and Osteoporosis and Factors Contributing to This Connection
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rheumatoid arthritis (RA) is an autoimmune chronic connective tissue disease that produces persistent systemic inflammation, with joint inflammation leading to function loss and joint destruction. It can finally lead to some serious systematic disorders, such as cardiovascular, pulmonary, skeletal, and psychological disorders.
One of the most severe comorbidities of RA is osteoporosis (OP), which is a chronic metabolic skeletal disease leading to an increased risk of low trauma fracture, and many factors can play a role in increasing this association including treating RA patients with glucocorticoid over a long duration, chronic joints inflammation, calcium malabsorption, age of the patients, and genetics.
Osteoporosis is characterized by microarchitectural deterioration of bone tissue and low bone mass. The most commonly used measurement for OP is bone mineral density (BMD) and DEXA (dual x-ray absorptiometry) Scans.
Osteoporosis can result in devastating physical, psychosocial, and economic consequences. Still, it is often overlooked and undertreated, in large part because it is clinically silent; there are no symptoms before a fracture occurs.
Epidemiological studies indicate that about 60-80% of RA patients have a comorbidity of OP.
These two kinds of complex diseases may share some common genetic mechanisms and biological processes. For example, proinflammatory cytokines including TNF-α, IL-17, IL-6, and IL-1 have been reported to be closely associated with OP, and they also play important roles in the development of RA. Also, the inflammation in the joints increases bone absorption and makes RA patients susceptible to bone loss and osteoporosis development.
One of the primary drugs recommended for the treatment of RA is a corticosteroid, glucocorticoid (GC). Both systemic corticosteroid and intraarticular corticosteroid are proven to be risk factors for developing secondary osteoporosis and osteoporotic fracture. The risk increases with the long duration of use and using a high dose. Longer duration and severity of RA were also indicated as independent risk factors for vertebral fractures. The American College of Rheumatology (ACR) recommended increasing the awareness of RA patients about BMD and getting DXA done for identifying a patient at risk of osteoporosis.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Felopateer Sedhom, Master
- Phone Number: +2 01223929829
- Email: felopateertalaat115@gmail.com
Study Contact Backup
- Name: Mostafa Haredy, MD
- Phone Number: +2 0100 107 9913
- Email: Mostafaharedy56@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Patient more than 18 years old classified as rheumatoid arthritis based on ACR/EULAR 2010 Classification criteria
- Patients with other clinical conditions that causes secondary osteoporosis as Diabetes Mellitus, renal, liver diseases, thyroid and parathyroid disorder excluded because of probability of these disease to be a reason of osteoporosis.
Description
Inclusion Criteria:
- Patient more than 18 years old classified as rheumatoid arthritis based on ACR/EULAR 2010 Classification criteria.
Exclusion Criteria:
- Patients with other clinical conditions that causes secondary osteoporosis as Diabetes Mellitus, renal, liver diseases, thyroid and parathyroid disorders.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The percentage of patients with Rheumatoid Arthritis who have Osteoporosis.
Time Frame: baseline
|
to explore the association between RA and osteoporosis and highlight the risk factors that RA patients have that may cause or affect osteoporosis progress by measuring the percentage of patents with RA who have osteoporosis.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between age, disease duration, disease activity, and treatment with osteoporosis
Time Frame: baseline
|
Correlation between age, disease duration, disease activity, and treatment with osteoporosis
|
baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
- Bone mineral density in patients with rheumatoid arthritis: relation between disease severity and low bone mineral density
- Clinical Use of Bone Densitometry
- IL-26 Is Overexpressed in Rheumatoid Arthritis and Induces Proinflammatory Cytokine Production and Th17 Cell Generation
- The prevalence of vertebral fracture on vertebral fracture assessment imaging in a large cohort of patients with rheumatoid arthritis
- Rheumatoid arthritis in adults: management
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RA&OP Relationship
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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