Multicenter Bone and Joint Health Study

University of California, San Francisco4,185 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

4,185

Conditions

Osteoarthritis,Knee

Eligibility

Sex: ALLMin age: 45 YearsMax age: 79 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (3)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Iowa

Iowa City, Iowa, United States

Boston University School of Medicine

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)

Secondary Outcomes

Onset of constant knee pain

Self- report

Time frame: 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

Time frame: 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

Time frame: Change from baseline (144-month) at 168-month follow-up contact

New onset knee buckling

Data from ClinicalTrials.gov

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