Multicenter Bone and Joint Health Study

Osteoarthritis,Knee Clinical Trial

— MOST  

Official title:

Multicenter Osteoarthritis Study (MOST) Second Renewal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03033238
• Other study ID #: U01AG019069
• Secondary ID: U01AG019069
• Status: Completed
• Start date: January 2003
• Est. completion date: December 2020

Study information

• Verified date: February 2021
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4185
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 79 Years

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Osteoarthritis,Knee

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Boston University School of Medicine	Boston	Massachusetts
United States	University of Iowa	Iowa City	Iowa

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Francisco	Boston University, National Institute on Aging (NIA), University of Alabama at Birmingham, University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Worsening knee pain	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	Change from baseline (144-month) at =2 follow-up contacts (152-, 160-, 168-month follow-up contacts)
Primary	Incident cartilage loss on MRI	Incidence of cartilage loss on MRI extending to the bone	Change from baseline (144-month) at 168-month follow-up contact
Primary	Function loss	Defined as minimally clinically important difference (MCID) for worsening on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function questionnaire	Change from baseline (144-month) at =2 follow-up contacts (152-, 160-, 168-month follow-up contacts)
Secondary	Onset of constant knee pain	Self- report	Change from baseline (144-month) at =2 follow-up contacts (152-, 160-, 168-month follow-up contacts)
Secondary	Worsening on MRI	Worsening cartilage scores, bone marrow lesion, or meniscal damage	Change from baseline (144-month) at 168-month follow-up contact
Secondary	Worsening on X-ray	Increased Kellgren-Lawrence (KL) grade score, new KL grade 2 score, or semi-quantitative joint space loss in any compartment	Change from baseline (144-month) at 168-month follow-up contact
Secondary	New onset knee buckling	Self-report	Change from baseline (144-month) at =1 follow-up contact (152-, 160-, 168-month follow-up contacts)
Secondary	New repeated falls	Self-report	Change from baseline (144-month) at =1 follow-up contact (152-, 160-, 168-month follow-up contacts)