<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/NCT01669954</url>
  </required_header>
  <id_info>
    <org_study_id>RJ1 09/0329</org_study_id>
    <secondary_id>08/H0805/56</secondary_id>
    <nct_id>NCT01669954</nct_id>
  </id_info>
  <brief_title>Determination of Optimum Age for DXA Screening for Osteoporosis in HIV - The Probono 1 Study</brief_title>
  <acronym>Probono1</acronym>
  <official_title>Prospective Study to Determine the Optimum Age for Routine DEXA Screening for Osteopenia/Osteoporosis in People With HIV Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St Thomas' Hospital, London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>King's College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the bone mineral density in male and female&#xD;
      patients with HIV infection according to age groups.&#xD;
&#xD;
      This will enable a practical approach to screening for osteoporosis and the management and&#xD;
      prevention of fragility fractures in people with HIV.&#xD;
&#xD;
      In addition, all risk factors commonly associated with fragility fractures and osteoporosis&#xD;
      are collected, as is HIV drug history.&#xD;
&#xD;
      Hence, as secondary outcomes, the associations with reduced bone mineral density can be&#xD;
      ascertained.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2009</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">May 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Bone mineral density at Hip</measure>
    <time_frame>The outcome is measured within 6 months (0-6 months) after entry to the study.</time_frame>
    <description>Bone mineral density as determined by DXA scanning</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bone mineral density at spine (L4)</measure>
    <time_frame>The outcome is measured within 6 months (0-6 months) after entry to the study.</time_frame>
    <description>As determined by DXA scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any lifetime fractures reported by subjects</measure>
    <time_frame>At any stage during persons life up to and including the last visit for the volunteer to the study.</time_frame>
    <description>Self-reported fractures of any type</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vitamin D levels</measure>
    <time_frame>The outcome is measured within 6 months (0-6 months) after entry to the study.</time_frame>
    <description>Plasma vitamin D</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">440</enrollment>
  <condition>Osteoporosis</condition>
  <condition>Fractures</condition>
  <condition>HIV Infection</condition>
  <arm_group>
    <arm_group_label>Controls, females</arm_group_label>
    <description>Controls who are presumed HIV uninfected, females, aged 18 or above</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls, males</arm_group_label>
    <description>Controls presumed HIV uninfected, males, aged 18 or above</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIV infected patients, males</arm_group_label>
    <description>HIV patients, males, aged 18 or above</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIV patients,</arm_group_label>
    <description>HIV patients, females, aged 18 or above</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma and urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        A randomly recruited numbers of HIV uninfected controls and HIV patients aged 18 years or&#xD;
        above, equally matched for age, and gender.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or above Not pregnant Able to comply with study observations and procedures&#xD;
             Able to give fully informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant Less than 18 years of age Unable to comply with study procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barry S Peters, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>King's College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St Thomas, Hospital</name>
      <address>
        <city>London</city>
        <zip>SE30AA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>August 17, 2012</last_update_submitted>
  <last_update_submitted_qc>August 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King's College London</investigator_affiliation>
    <investigator_full_name>Barry Stephen Peters</investigator_full_name>
    <investigator_title>Reader and Consultant HIV Medicine, Head of Research Unit, Principle Investigator, Clinical Researcher</investigator_title>
  </responsible_party>
  <keyword>HIV</keyword>
  <keyword>Bone mineral density</keyword>
  <keyword>Osteoporosis</keyword>
  <keyword>Vitamin D</keyword>
  <keyword>Fractures</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>HIV Infections</mesh_term>
    <mesh_term>Acquired Immunodeficiency Syndrome</mesh_term>
    <mesh_term>Osteoporosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT01669954
org study id: RJ1 09/0329
secondary id: 08/H0805/56
nct id: NCT01669954
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine the bone mineral density in male and female
      patients with HIV infection according to age groups.

      This will enable a practical approach to screening for osteoporosis and the management and
      prevention of fragility fractures in people with HIV.

      In addition, all risk factors commonly associated with fragility fractures and osteoporosis
      are collected, as is HIV drug history.

      Hence, as secondary outcomes, the associations with reduced bone mineral density can be
      ascertained.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Bone mineral density at Hip
time frame: The outcome is measured within 6 months (0-6 months) after entry to the study.
description: Bone mineral density as determined by DXA scanning
measure: Bone mineral density at spine (L4)
time frame: The outcome is measured within 6 months (0-6 months) after entry to the study.
description: As determined by DXA scan
measure: Any lifetime fractures reported by subjects
time frame: At any stage during persons life up to and including the last visit for the volunteer to the study.
description: Self-reported fractures of any type
measure: Vitamin D levels
time frame: The outcome is measured within 6 months (0-6 months) after entry to the study.
description: Plasma vitamin D
arm group label: Controls, females
description: Controls who are presumed HIV uninfected, females, aged 18 or above
arm group label: Controls, males
description: Controls presumed HIV uninfected, males, aged 18 or above
arm group label: HIV infected patients, males
description: HIV patients, males, aged 18 or above
arm group label: HIV patients,
description: HIV patients, females, aged 18 or above
Plasma and urine
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Barry S Peters, MD PhD
role: Principal Investigator
affiliation: King's College London
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: King's College London
investigator full name: Barry Stephen Peters
investigator title: Reader and Consultant HIV Medicine, Head of Research Unit, Principle Investigator, Clinical Researcher
mesh term: Infections
mesh term: HIV Infections
mesh term: Acquired Immunodeficiency Syndrome
mesh term: Osteoporosis