<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/NCT03033238</url>
  </required_header>
  <id_info>
    <org_study_id>U01AG019069</org_study_id>
    <secondary_id>U01AG019069</secondary_id>
    <nct_id>NCT03033238</nct_id>
  </id_info>
  <brief_title>Multicenter Bone and Joint Health Study</brief_title>
  <acronym>MOST</acronym>
  <official_title>Multicenter Osteoarthritis Study (MOST) Second Renewal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Iowa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate opportunities for prevention and treatment of&#xD;
      knee osteoarthritis (OA) by evaluating potentially modifiable risk factors for disease and&#xD;
      poor pain and physical function outcomes especially among those with early or mild knee&#xD;
      symptoms. The goal of the study is to find novel strategies to prevent disease at an early&#xD;
      stage and to limit the impact of disease once it has occurred.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MOST study participants in the &quot;Existing Cohort&quot; (3,026 subjects) were enrolled in the&#xD;
      original study in 2003-2005. Surviving Existing Cohort participants without end-stage knee&#xD;
      osteoarthritis will be asked to participate in the 144-, 152-, 160- and 168-month follow-up&#xD;
      contacts. In addition, in 2016-2018 the cohort will be enriched by the recruitment of an&#xD;
      additional 1,500 &quot;New Cohort&quot; participants with early or mild knee symptoms. The goal of the&#xD;
      study is to find novel strategies to prevent disease at an early stage.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2003</start_date>
  <completion_date type="Actual">December 2020</completion_date>
  <primary_completion_date type="Actual">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Worsening knee pain</measure>
    <time_frame>Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)</time_frame>
    <description>Worsening knee pain defined as reaching minimally clinically important difference (MCID) for worsening on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incident cartilage loss on MRI</measure>
    <time_frame>Change from baseline (144-month) at 168-month follow-up contact</time_frame>
    <description>Incidence of cartilage loss on MRI extending to the bone</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Function loss</measure>
    <time_frame>Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)</time_frame>
    <description>Defined as minimally clinically important difference (MCID) for worsening on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Onset of constant knee pain</measure>
    <time_frame>Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)</time_frame>
    <description>Self- report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Worsening on MRI</measure>
    <time_frame>Change from baseline (144-month) at 168-month follow-up contact</time_frame>
    <description>Worsening cartilage scores, bone marrow lesion, or meniscal damage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Worsening on X-ray</measure>
    <time_frame>Change from baseline (144-month) at 168-month follow-up contact</time_frame>
    <description>Increased Kellgren-Lawrence (KL) grade score, new KL grade 2 score, or semi-quantitative joint space loss in any compartment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New onset knee buckling</measure>
    <time_frame>Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts)</time_frame>
    <description>Self-report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New repeated falls</measure>
    <time_frame>Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts)</time_frame>
    <description>Self-report</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">4185</enrollment>
  <condition>Osteoarthritis,Knee</condition>
  <arm_group>
    <arm_group_label>Early or mild knee symptoms</arm_group_label>
    <description>Existing Cohort study participants (3,026) were enrolled in 2003-2005, Surviving participants without endstage knee osteoarthritis will be asked to participate in the 144-, 152-, 160- and 168-month follow-up contacts [2,660 were enrolled].&#xD;
New Cohort study participants (1,500) will be recruited and enrolled in 2016-2018 [1,525 were enrolled].</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Existing Cohort biospecimens were collected at enrollment, 30-month and 60-month follow-up.&#xD;
      New Cohort biospecimens will be collected at 144-month which will be their enrollment visit).&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The purpose of this study is to investigate opportunities for prevention and treatment of&#xD;
        knee osteoarthritis by evaluating potentially modifiable risk factors for disease and poor&#xD;
        pain and physical function outcomes especially among those with early or mild knee&#xD;
        symptoms. The goal of the study is to find novel strategies to prevent disease at an early&#xD;
        stage and to limit the impact of disease once it has occurred.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for &quot;New Cohort&quot; Participants:&#xD;
&#xD;
          -  Age 45 to 69 Years (Adult, Senior)&#xD;
&#xD;
          -  Males and Females&#xD;
&#xD;
          -  Healthy Volunteers&#xD;
&#xD;
          -  Community-based Sample&#xD;
&#xD;
        Exclusion Criteria for &quot;New Cohort&quot; Participants:&#xD;
&#xD;
          -  Rheumatoid or inflammatory arthritis (based on self-report and use of medications&#xD;
             specific to these conditions)&#xD;
&#xD;
          -  Serious health condition e.g., end-stage renal disease, etc. that would likely limit&#xD;
             follow-up to less than 2-3 years&#xD;
&#xD;
          -  Plan to relocate out of geographic region in next 3 years&#xD;
&#xD;
          -  Not able to walk without the aid of a person or assistive device&#xD;
&#xD;
          -  Knee joint replacement surgery in either knee&#xD;
&#xD;
          -  Neither knee fits in the MRI knee coil (determined during Screening Visit).&#xD;
&#xD;
          -  Not competent to give informed consent&#xD;
&#xD;
          -  Advanced structural tibiofemoral or patellofemoral knee OA disease (KL grade 3 or 4)&#xD;
             in either knee (Determined by Knee X-ray Screening)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Nevitt, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston University School of Medicine</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>February 12, 2021</last_update_submitted>
  <last_update_submitted_qc>February 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized clinical data will be shared via The NIA Biobank (https://agingresearchbiobank.nia.nih.gov/). MOST Existing Cohort data from previous grant cycles will be available in mid 2021. For more information visit MOST Online (https://most.ucsf.edu).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_access_criteria>See NIA Biobank website</ipd_access_criteria>
    <ipd_url>https://agingresearchbiobank.nia.nih.gov/</ipd_url>
  </patient_data>
  <!-- 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/NCT03033238
org study id: U01AG019069
secondary id: U01AG019069
nct id: NCT03033238
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to investigate opportunities for prevention and treatment of
      knee osteoarthritis (OA) by evaluating potentially modifiable risk factors for disease and
      poor pain and physical function outcomes especially among those with early or mild knee
      symptoms. The goal of the study is to find novel strategies to prevent disease at an early
      stage and to limit the impact of disease once it has occurred.
MOST study participants in the "Existing Cohort" (3,026 subjects) were enrolled in the
      original study in 2003-2005. Surviving Existing Cohort participants without end-stage knee
      osteoarthritis will be asked to participate in the 144-, 152-, 160- and 168-month follow-up
      contacts. In addition, in 2016-2018 the cohort will be enriched by the recruitment of an
      additional 1,500 "New Cohort" participants with early or mild knee symptoms. The goal of the
      study is to find novel strategies to prevent disease at an early stage.
observational model: Cohort
time perspective: Prospective
measure: Worsening knee pain
time frame: Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)
description: Worsening knee pain defined as reaching minimally clinically important difference (MCID) for worsening on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain questionnaire
measure: Incident cartilage loss on MRI
time frame: Change from baseline (144-month) at 168-month follow-up contact
description: Incidence of cartilage loss on MRI extending to the bone
measure: Function loss
time frame: Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)
description: Defined as minimally clinically important difference (MCID) for worsening on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function questionnaire
measure: Onset of constant knee pain
time frame: Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)
description: Self- report
measure: Worsening on MRI
time frame: Change from baseline (144-month) at 168-month follow-up contact
description: Worsening cartilage scores, bone marrow lesion, or meniscal damage
measure: Worsening on X-ray
time frame: Change from baseline (144-month) at 168-month follow-up contact
description: Increased Kellgren-Lawrence (KL) grade score, new KL grade 2 score, or semi-quantitative joint space loss in any compartment
measure: New onset knee buckling
time frame: Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts)
description: Self-report
measure: New repeated falls
time frame: Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts)
description: Self-report
arm group label: Early or mild knee symptoms
description: Existing Cohort study participants (3,026) were enrolled in 2003-2005, Surviving participants without endstage knee osteoarthritis will be asked to participate in the 144-, 152-, 160- and 168-month follow-up contacts [2,660 were enrolled].
New Cohort study participants (1,500) will be recruited and enrolled in 2016-2018 [1,525 were enrolled].
Existing Cohort biospecimens were collected at enrollment, 30-month and 60-month follow-up.
      New Cohort biospecimens will be collected at 144-month which will be their enrollment visit).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: 79 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Nevitt, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: Yes
ipd description: Anonymized clinical data will be shared via The NIA Biobank (https://agingresearchbiobank.nia.nih.gov/). MOST Existing Cohort data from previous grant cycles will be available in mid 2021. For more information visit MOST Online (https://most.ucsf.edu).
ipd info type: Study Protocol
ipd access criteria: See NIA Biobank website
ipd url: https://agingresearchbiobank.nia.nih.gov/