xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06038292</url>
    </required_header>
    <id_info>
      <org_study_id>RA&amp;OP Relationship</org_study_id>
      <nct_id>NCT06038292</nct_id>
    </id_info>
    <brief_title>The Relationship Between Rheumatoid Arthritis and Osteoporosis and Factors Contributing to This Connection</brief_title>
    <official_title>The Relationship Between Rheumatoid Arthritis and Osteoporosis and Factors Contributing to This Connection</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to explore the association between RA and osteoporosis and highlight the risk&#xD;
        factors that RA patients have that may cause or affect osteoporosis progress.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Rheumatoid arthritis (RA) is an autoimmune chronic connective tissue disease that produces&#xD;
        persistent systemic inflammation, with joint inflammation leading to function loss and joint&#xD;
        destruction. It can finally lead to some serious systematic disorders, such as&#xD;
        cardiovascular, pulmonary, skeletal, and psychological disorders.&#xD;
  &#xD;
        One of the most severe comorbidities of RA is osteoporosis (OP), which is a chronic metabolic&#xD;
        skeletal disease leading to an increased risk of low trauma fracture, and many factors can&#xD;
        play a role in increasing this association including treating RA patients with glucocorticoid&#xD;
        over a long duration, chronic joints inflammation, calcium malabsorption, age of the&#xD;
        patients, and genetics.&#xD;
  &#xD;
        Osteoporosis is characterized by microarchitectural deterioration of bone tissue and low bone&#xD;
        mass. The most commonly used measurement for OP is bone mineral density (BMD) and DEXA (dual&#xD;
        x-ray absorptiometry) Scans.&#xD;
  &#xD;
        Osteoporosis can result in devastating physical, psychosocial, and economic consequences.&#xD;
        Still, it is often overlooked and undertreated, in large part because it is clinically&#xD;
        silent; there are no symptoms before a fracture occurs.&#xD;
  &#xD;
        Epidemiological studies indicate that about 60-80% of RA patients have a comorbidity of OP.&#xD;
  &#xD;
        These two kinds of complex diseases may share some common genetic mechanisms and biological&#xD;
        processes. For example, proinflammatory cytokines including TNF-α, IL-17, IL-6, and IL-1 have&#xD;
        been reported to be closely associated with OP, and they also play important roles in the&#xD;
        development of RA. Also, the inflammation in the joints increases bone absorption and makes&#xD;
        RA patients susceptible to bone loss and osteoporosis development.&#xD;
  &#xD;
        One of the primary drugs recommended for the treatment of RA is a corticosteroid,&#xD;
        glucocorticoid (GC). Both systemic corticosteroid and intraarticular corticosteroid are&#xD;
        proven to be risk factors for developing secondary osteoporosis and osteoporotic fracture.&#xD;
        The risk increases with the long duration of use and using a high dose. Longer duration and&#xD;
        severity of RA were also indicated as independent risk factors for vertebral fractures. The&#xD;
        American College of Rheumatology (ACR) recommended increasing the awareness of RA patients&#xD;
        about BMD and getting DXA done for identifying a patient at risk of osteoporosis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">November 2026</completion_date>
    <primary_completion_date type="Anticipated">October 2026</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <target_duration>8 Months</target_duration>
    <primary_outcome>
      <measure>The percentage of patients with Rheumatoid Arthritis who have Osteoporosis.</measure>
      <time_frame>baseline</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Correlation between age, disease duration, disease activity, and treatment with osteoporosis</measure>
      <time_frame>baseline</time_frame>
      <description>Correlation between age, disease duration, disease activity, and treatment with osteoporosis</description>
    </secondary_outcome>
    <enrollment type="Anticipated">105</enrollment>
    <condition>RA &amp; OP Relationship</condition>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>DXA Scan</intervention_name>
      <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.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patient more than 18 years old classified as rheumatoid arthritis based on ACR/EULAR 2010&#xD;
          Classification criteria&#xD;
  &#xD;
            -  Patients with other clinical conditions that causes secondary osteoporosis as Diabetes&#xD;
               Mellitus, renal, liver diseases, thyroid and parathyroid disorder excluded because of&#xD;
               probability of these disease to be a reason of osteoporosis.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient more than 18 years old classified as rheumatoid arthritis based on ACR/EULAR&#xD;
               2010 Classification criteria.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with other clinical conditions that causes secondary osteoporosis as Diabetes&#xD;
               Mellitus, renal, liver diseases, thyroid and parathyroid disorders.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Felopateer Sedhom, Master</last_name>
      <phone>+2 01223929829</phone>
      <email>felopateertalaat115@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mostafa Haredy, MD</last_name>
      <phone>+2 0100 107 9913</phone>
      <email>Mostafaharedy56@gmail.com</email>
    </overall_contact_backup>
    <link>
      <url>https://ard.bmj.com/content/63/12/1576</url>
      <description>Bone mineral density in patients with rheumatoid arthritis: relation between disease severity and low bone mineral density</description>
    </link>
    <link>
      <url>https://jamanetwork.com/journals/jama/fullarticle/195421</url>
      <description>Clinical Use of Bone Densitometry</description>
    </link>
    <link>
      <url>https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.1001395</url>
      <description>IL-26 Is Overexpressed in Rheumatoid Arthritis and Induces Proinflammatory Cytokine Production and Th17 Cell Generation</description>
    </link>
    <link>
      <url>http://doi.org/10.1093/rheumatology/ket353</url>
      <description>The prevalence of vertebral fracture on vertebral fracture assessment imaging in a large cohort of patients with rheumatoid arthritis</description>
    </link>
    <link>
      <url>http://www.nice.org.uk/guidance/cg79</url>
      <description>Rheumatoid arthritis in adults: management</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Felopateer Talaat Sedhom</investigator_full_name>
      <investigator_title>felopateer talaat</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoporosis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06038292
  org study id: RA&OP Relationship
  nct id: NCT06038292
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: The percentage of patients with Rheumatoid Arthritis who have Osteoporosis.
  time frame: 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.
  measure: Correlation between age, disease duration, disease activity, and treatment with osteoporosis
  time frame: baseline
  description: Correlation between age, disease duration, disease activity, and treatment with osteoporosis
  intervention type: Radiation
  intervention name: DXA Scan
  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.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Felopateer Sedhom, Master
  phone: +2 01223929829
  email: felopateertalaat115@gmail.com
  last name: Mostafa Haredy, MD
  phone: +2 0100 107 9913
  email: Mostafaharedy56@gmail.com
  url: https://ard.bmj.com/content/63/12/1576
  description: Bone mineral density in patients with rheumatoid arthritis: relation between disease severity and low bone mineral density
  url: https://jamanetwork.com/journals/jama/fullarticle/195421
  description: Clinical Use of Bone Densitometry
  url: https://journals.plos.org/plosbiology/article?id=10.1371/journal.pbio.1001395
  description: IL-26 Is Overexpressed in Rheumatoid Arthritis and Induces Proinflammatory Cytokine Production and Th17 Cell Generation
  url: http://doi.org/10.1093/rheumatology/ket353
  description: The prevalence of vertebral fracture on vertebral fracture assessment imaging in a large cohort of patients with rheumatoid arthritis
  url: http://www.nice.org.uk/guidance/cg79
  description: Rheumatoid arthritis in adults: management
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Felopateer Talaat Sedhom
  investigator title: felopateer talaat
  mesh term: Osteoporosis