The Relationship Between Rheumatoid Arthritis and Osteoporosis and Factors Contributing to This Connection

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06038292
Collaborator
(none)
105
37

Study Details

Study Description

Brief Summary

This study aims to explore the association between RA and osteoporosis and highlight the risk factors that RA patients have that may cause or affect osteoporosis progress.

Condition or Disease Intervention/Treatment Phase
  • Radiation: DXA Scan

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
105 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
The Relationship Between Rheumatoid Arthritis and Osteoporosis and Factors Contributing to This Connection
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2026
Anticipated Study Completion Date :
Nov 1, 2026

Outcome Measures

Primary Outcome Measures

  1. The percentage of patients with Rheumatoid Arthritis who have Osteoporosis. [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.

Secondary Outcome Measures

  1. Correlation between age, disease duration, disease activity, and treatment with osteoporosis [baseline]

    Correlation between age, disease duration, disease activity, and treatment with osteoporosis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Felopateer Talaat Sedhom, felopateer talaat, Assiut University
ClinicalTrials.gov Identifier:
NCT06038292
Other Study ID Numbers:
  • RA&OP Relationship
First Posted:
Sep 14, 2023
Last Update Posted:
Sep 14, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2023