Multicenter Bone and Joint Health Study (MOST)

Multicenter Osteoarthritis Study (MOST) Second Renewal

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis,Knee

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 Type: Observational
• Enrollment (Actual): 4185

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Iowa
    • Iowa City, Iowa, United States, 52240
      • University of Iowa
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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].

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Boston University; University of Alabama at Birmingham; University of Iowa; National Institute on Aging (NIA)
• Investigators: Principal Investigator: Michael Nevitt, PhD, University of California, San Francisco

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: December 1, 2016
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (Estimate): January 26, 2017

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: U01AG019069 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized clinical data will be shared via The NIA Biobank (https://agingresearchbiobank.nia.nih.gov/). MOST Existing Cohort data from previous grant cycles will be available in mid 2021. For more information visit MOST Online (https://most.ucsf.edu).
• IPD Sharing Access Criteria: See NIA Biobank website
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL