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

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ClinicalTrials.gov Identifier: NCT06038292
Recruitment Status : Not yet recruiting
First Posted : September 14, 2023
Last Update Posted : February 21, 2024
Sponsor:
Information provided by (Responsible Party):
Felopateer Talaat Sedhom, Assiut University

Study Description
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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
RA & OP Relationship 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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 8 Months
Official Title: The Relationship Between Rheumatoid Arthritis and Osteoporosis and Factors Contributing to This Connection
Estimated Study Start Date : March 1, 2024
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : November 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Radiation: DXA Scan
    DEXA (dual x-ray absorptiometry) Scans which measure bone density (thickness and strength of bones) by passing a high and low energy x-ray beam (a form of ionizing radiation) through the body, usually in the hip, the spine and the bones of the hands and can easily diagnose osteoporosis.

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06038292


Contacts
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Contact: Felopateer Sedhom, Master +2 01223929829 felopateertalaat115@gmail.com
Contact: Mostafa Haredy, MD +2 0100 107 9913 Mostafaharedy56@gmail.com

Sponsors and Collaborators
Assiut University
More Information
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Additional Information:

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Responsible Party: Felopateer Talaat Sedhom, felopateer talaat, Assiut University
ClinicalTrials.gov Identifier: NCT06038292    
Other Study ID Numbers: RA&OP Relationship
First Posted: September 14, 2023    Key Record Dates
Last Update Posted: February 21, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Musculoskeletal Diseases
Bone Diseases, Metabolic
Bone Diseases
Metabolic Diseases