Skip to main content
OpenTrials
Completed

NCT Number: NCT03033238

Multicenter Bone and Joint Health Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

45 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. New repeated falls

    Time frame: Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts)

    Self-report

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Boston University
  • National Institute on Aging (NIA)
  • University of Alabama at Birmingham
  • University of Iowa

Registry information

Official study title

Multicenter Osteoarthritis Study (MOST) Second Renewal

Acronym: MOST

Important dates

Study start
2003
Primary completion
2020
Study completion
2020
First posted
Jan 26, 2017
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.