Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-25 @ 6:21 PM
Study NCT ID:
NCT06038292
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-21
First Post:
2023-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Rheumatoid Arthritis and Osteoporosis and Factors Contributing to This Connection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015502', 'term': 'Absorptiometry, Photon'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}, 'targetDuration': '8 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-20', 'studyFirstSubmitDate': '2023-09-08', 'studyFirstSubmitQcDate': '2023-09-13', 'lastUpdatePostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of patients with Rheumatoid Arthritis who have Osteoporosis.', 'timeFrame': 'baseline', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Correlation between age, disease duration, disease activity, and treatment with osteoporosis', 'timeFrame': 'baseline', 'description': 'Correlation between age, disease duration, disease activity, and treatment with osteoporosis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['RA & OP Relationship']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://ard.bmj.com/content/63/12/1576', 'label': 'Bone mineral density in patients with rheumatoid arthritis: relation between disease severity and low bone mineral density'}, {'url': 'https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.1001395', 'label': 'IL-26 Is Overexpressed in Rheumatoid Arthritis and Induces Proinflammatory Cytokine Production and Th17 Cell Generation'}, {'url': 'http://www.nice.org.uk/guidance/cg79', 'label': 'Rheumatoid arthritis in adults: management'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nOne 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.\n\nOsteoporosis 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.\n\nOsteoporosis 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.\n\nEpidemiological studies indicate that about 60-80% of RA patients have a comorbidity of OP.\n\nThese 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.\n\nOne 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient more than 18 years old classified as rheumatoid arthritis based on ACR/EULAR 2010 Classification criteria\n\n* 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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient more than 18 years old classified as rheumatoid arthritis based on ACR/EULAR 2010 Classification criteria.\n\nExclusion Criteria:\n\n* Patients with other clinical conditions that causes secondary osteoporosis as Diabetes Mellitus, renal, liver diseases, thyroid and parathyroid disorders.'}, 'identificationModule': {'nctId': 'NCT06038292', 'briefTitle': 'The Relationship Between Rheumatoid Arthritis and Osteoporosis and Factors Contributing to This Connection', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Relationship Between Rheumatoid Arthritis and Osteoporosis and Factors Contributing to This Connection', 'orgStudyIdInfo': {'id': 'RA&OP Relationship'}}, 'armsInterventionsModule': {'interventions': [{'name': 'DXA Scan', 'type': 'RADIATION', 'description': '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.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Felopateer Sedhom, Master', 'role': 'CONTACT', 'email': 'felopateertalaat115@gmail.com', 'phone': '+2 01223929829'}, {'name': 'Mostafa Haredy, MD', 'role': 'CONTACT', 'email': 'Mostafaharedy56@gmail.com', 'phone': '+2 0100 107 9913'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'felopateer talaat', 'investigatorFullName': 'Felopateer Talaat Sedhom', 'investigatorAffiliation': 'Assiut University'}}}}