Multicenter Bone and Joint Health Study

Completed

• Conditions: Osteoarthritis,Knee

• Registration Number: NCT03033238
• Lead Sponsor: University of California, San Francisco

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 Timeline

• Study Start: 2003-01
• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-26
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-12
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4185

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incident cartilage loss on MRI	Change from baseline (144-month) at 168-month follow-up contact	Incidence of cartilage loss on MRI extending to the bone
Worsening knee pain	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
Function loss	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 Outcome Measures

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

Trial Locations

Locations (3)

Boston University School of Medicine; 🇺🇸 Boston, Massachusetts, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States