Multicenter Bone and Joint Health Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicenter Osteoarthritis Study (MOST) Second Renewal

Conditions
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Osteoarthritis,Knee

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early or mild knee symptoms<br>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]. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of constant knee pain | Self- report | Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts) | 
| Worsening on MRI | Worsening cartilage scores, bone marrow lesion, or meniscal damage | Change from baseline (144-month) at 168-month follow-up contact | 
| 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 | 
| New onset knee buckling | Self-report | Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts) | 
| New repeated falls | Self-report | Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts) |