Multicenter Bone and Joint Health Study

NCT03033238 | Completed

• 1 other identifier: U01AG019069
• Study Type: observational
• Target: 4,185
• Locations: 1 country
• Sites: 3

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.

Conditions

Osteoarthritis,Knee

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Onset of constant knee pain

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

• Worsening on MRI

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

• Worsening on X-ray

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

• New onset knee buckling

  Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts)

• New repeated falls

  Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts)

Study Arms (1)

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 \[1,525 were enrolled\].

Eligibility Criteria

• Age: 45 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The purpose of this study is to investigate opportunities for prevention and treatment of knee osteoarthritis 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of Iowa: collaborator
• University of Alabama at Birmingham: collaborator
• Boston University: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Iowa

Iowa City, Iowa, 52240, United States

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• 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.

  PMID: 34620738 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Existing Cohort biospecimens were collected at enrollment, 30-month and 60-month follow-up. New Cohort biospecimens will be collected at 144-month which will be their enrollment visit).

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Michael Nevitt, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: January 26, 2017
• Study Start: January 1, 2003
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: See NIA Biobank website

Locations

US (3)