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Multicenter Bone and Joint Health Study (MOST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03033238
Recruitment Status : Active, not recruiting
First Posted : January 26, 2017
Last Update Posted : May 11, 2020
Sponsor:
Collaborators:
University of Iowa
University of Alabama at Birmingham
Boston University
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date December 1, 2016
First Posted Date January 26, 2017
Last Update Posted Date May 11, 2020
Study Start Date January 2003
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 24, 2017)
  • Worsening knee pain [ Time Frame: Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts) ]
    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
  • Incident cartilage loss on MRI [ Time Frame: Change from baseline (144-month) at 168-month follow-up contact ]
    Incidence of cartilage loss on MRI extending to the bone
  • Function loss [ Time Frame: Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts) ]
    Defined as minimally clinically important difference (MCID) for worsening on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function questionnaire
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 24, 2017)
  • Onset of constant knee pain [ Time Frame: Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts) ]
    Self- report
  • Worsening on MRI [ Time Frame: Change from baseline (144-month) at 168-month follow-up contact ]
    Worsening cartilage scores, bone marrow lesion, or meniscal damage
  • Worsening on X-ray [ Time Frame: Change from baseline (144-month) at 168-month follow-up contact ]
    Increased Kellgren-Lawrence (KL) grade score, new KL grade 2 score, or semi-quantitative joint space loss in any compartment
  • New onset knee buckling [ Time Frame: Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts) ]
    Self-report
  • New repeated falls [ Time Frame: Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts) ]
    Self-report
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multicenter Bone and Joint Health Study
Official Title Multicenter Osteoarthritis Study (MOST) Second Renewal
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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).
Sampling Method Probability Sample
Study Population The purpose of this study is to investigate opportunities for prevention and treatment of knee osteoarthritis 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.
Condition Osteoarthritis,Knee
Intervention Not Provided
Study Groups/Cohorts Early or mild knee symptoms

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.

New Cohort study participants (1,500) will be recruited and enrolled in 2016-2018.

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: January 24, 2017)
4526
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2021
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria for "New Cohort" Participants:

  • Age 45 to 69 Years (Adult, Senior)
  • Males and Females
  • Healthy Volunteers
  • Community-based Sample

Exclusion Criteria for "New Cohort" Participants:

  • Rheumatoid or inflammatory arthritis (based on self-report and use of medications specific to these conditions)
  • Serious health condition e.g., end-stage renal disease, etc. that would likely limit follow-up to less than 2-3 years
  • Plan to relocate out of geographic region in next 3 years
  • Not able to walk without the aid of a person or assistive device
  • Knee joint replacement surgery in either knee
  • Neither knee fits in the MRI knee coil (determined during Screening Visit).
  • Not competent to give informed consent
  • Advanced structural tibiofemoral or patellofemoral knee OA disease (KL grade 3 or 4) in either knee (Determined by Knee X-ray Screening)
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03033238
Other Study ID Numbers U01AG019069( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Anonymized clinical data is shared via MOST Online (http:\\most.ucsf.edu); 144-month through 168-month follow-up data is planned for release in 2021
Responsible Party University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators
  • University of Iowa
  • University of Alabama at Birmingham
  • Boston University
Investigators
Principal Investigator: Michael Nevitt, PhD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date May 2020