Multicenter Bone and Joint Health Study

NCT ID: NCT03033238

Last Updated: 2021-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4185 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Study Completion Date

2020-12-31

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.

Conditions

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Osteoarthritis,Knee

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Early or mild knee symptoms

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 \[1,525 were enrolled\].

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age 45 to 69 Years (Adult, Senior)
* Males and Females
* Healthy Volunteers
* Community-based Sample

Exclusion Criteria

* 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)
Minimum Eligible Age

45 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Iowa

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Nevitt, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Boston University School of Medicine

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Rabe KG, Stockman TJ, Kern AM, Wirth W, Eckstein F, Sharma L, Lynch JA, Nevitt MC, Anderson DD, Segal NA. Longitudinal Relationship Between Tibiofemoral Contact Stress at Baseline and Worsening of Knee Pain Over 84 Months in the Multicenter Osteoarthritis Study. Am J Phys Med Rehabil. 2022 Aug 1;101(8):726-732. doi: 10.1097/PHM.0000000000001899. Epub 2021 Oct 8.

Reference Type DERIVED
PMID: 34620738 (View on PubMed)

Other Identifiers

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U01AG019069

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01AG019069

Identifier Type: NIH

Identifier Source: org_study_id

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