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/NCT05993130</url>
    </required_header>
    <id_info>
      <org_study_id>Kayseri City Hospital</org_study_id>
      <nct_id>NCT05993130</nct_id>
    </id_info>
    <brief_title>Evaluation of Patients With Covid-19 Infection in Terms of Severity of Osteoprosis</brief_title>
    <official_title>Kayseri City (Education and Research) Hospital</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kayseri Education and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kayseri Education and Research Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Osteoporosis is a condition characterized by decreased bone strength and an increased risk of&#xD;
        fracture. Age, gender, body mass index, fragility fracture history, corticosteroid use,&#xD;
        immobilization, smoking and alcohol use, endocrine pathologies besides inflammatory and&#xD;
        infectious pathologies can also be effective in the development of osteoporosis. The aim of&#xD;
        the study is to evaluate the effect of Covid-19 infection on the development of osteoporosis.&#xD;
  &#xD;
        In this study, bone mineral density (BMD) measurements of patients with Covid-19 infection&#xD;
        were examined. For this, dual-energy x-ray absorptiometry (DEXA) measurement was used. A&#xD;
        total of 55 patients were included in the study and data such as age, height, weight,&#xD;
        comorbidities, drugs used, and treatment methods were recorded. Results showed that the time&#xD;
        spent in the intensive care unit was associated with the femoral neck T score in DEXA&#xD;
        measurements of patients with Covid-19 infection. The use of drugs such as alendronate,&#xD;
        zolendronate, denosumab or teriparatide during the treatment process did not have a&#xD;
        statistically significant effect on the lumbar and femur T scores.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 15, 2021</start_date>
    <completion_date type="Actual">December 15, 2022</completion_date>
    <primary_completion_date type="Actual">December 15, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Does the severity of osteoporosis increase in patients with Covid-19 infection?</measure>
      <time_frame>2020 August 2021 July</time_frame>
    </primary_outcome>
    <enrollment type="Actual">55</enrollment>
    <condition>Severity of Osteoprosis</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>The patients were not intervened. This is a retrospective study</intervention_name>
      <description>The patients were not intervened. This is a retrospective study</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Between August 2020 and July 2021, two separate excel files were created for the&#xD;
          identification numbers of the patients who had DEXA measurements and the identification&#xD;
          numbers of the patients who had covid. Then, common ID numbers were found in both excel&#xD;
          files in the computer environment. Among these patients, female patients over the age of 18&#xD;
          who had dexa measurements twice before and after covid, with at least one year between two&#xD;
          dexa measurements and at least one month after covid infection were included in the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female patients over the age of 18 who had dexa measurements twice before and after&#xD;
               covid, with at least one year between two dexa measurements, and at least one month&#xD;
               after covid infection were included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Under the age of 18, male patients, patients with a diagnosis other than Covid-19&#xD;
               infection that will affect bone metabolism between the two dexa shooting dates before&#xD;
               and after covid, patients who use another drug other than covid treatment that will&#xD;
               affect bone metabolism between the two dexa shooting dates before and after covid not&#xD;
               included in the study&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Physically and anatomically female patients were included. There was no difference in the patients included in our study.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Kayseri City Hospital</name>
        <address>
          <city>Kayseri</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kayseri Education and Research Hospital</investigator_affiliation>
      <investigator_full_name>Dr. Ayşe Güç</investigator_full_name>
      <investigator_title>physical medicine and rehabilitation</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05993130
  org study id: Kayseri City Hospital
  nct id: NCT05993130
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Osteoporosis is a condition characterized by decreased bone strength and an increased risk of
        fracture. Age, gender, body mass index, fragility fracture history, corticosteroid use,
        immobilization, smoking and alcohol use, endocrine pathologies besides inflammatory and
        infectious pathologies can also be effective in the development of osteoporosis. The aim of
        the study is to evaluate the effect of Covid-19 infection on the development of osteoporosis.
  
        In this study, bone mineral density (BMD) measurements of patients with Covid-19 infection
        were examined. For this, dual-energy x-ray absorptiometry (DEXA) measurement was used. A
        total of 55 patients were included in the study and data such as age, height, weight,
        comorbidities, drugs used, and treatment methods were recorded. Results showed that the time
        spent in the intensive care unit was associated with the femoral neck T score in DEXA
        measurements of patients with Covid-19 infection. The use of drugs such as alendronate,
        zolendronate, denosumab or teriparatide during the treatment process did not have a
        statistically significant effect on the lumbar and femur T scores.
  observational model: Other
  time perspective: Retrospective
  measure: Does the severity of osteoporosis increase in patients with Covid-19 infection?
  time frame: 2020 August 2021 July
  intervention type: Other
  intervention name: The patients were not intervened. This is a retrospective study
  description: The patients were not intervened. This is a retrospective study
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Physically and anatomically female patients were included. There was no difference in the patients included in our study.
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Kayseri Education and Research Hospital
  investigator full name: Dr. Ayşe Güç
  investigator title: physical medicine and rehabilitation
  sharing ipd: No