Clinical trial NCT03033238: Multicenter Bone and Joint Health Study
Official title: Multicenter Osteoarthritis Study (MOST) Second Renewal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis,Knee
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Iowa
name: University of Alabama at Birmingham
name: Boston University
name: National Institute on Aging (NIA)
First posted: 2017-01-26
Enrollment: 4185
Sex: ALL
Minimum age (years): 45
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Worsening knee pain
timeFrame: Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)
measure: Incident cartilage loss on MRI
timeFrame: Change from baseline (144-month) at 168-month follow-up contact
measure: Function loss
timeFrame: Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)
Secondary outcomes:
measure: Onset of constant knee pain
timeFrame: Change from baseline (144-month) at ≥2 follow-up contacts (152-, 160-, 168-month follow-up contacts)
measure: Worsening on MRI
timeFrame: Change from baseline (144-month) at 168-month follow-up contact
measure: Worsening on X-ray
timeFrame: Change from baseline (144-month) at 168-month follow-up contact
measure: New onset knee buckling
timeFrame: Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts)
measure: New repeated falls
timeFrame: Change from baseline (144-month) at ≥1 follow-up contact (152-, 160-, 168-month follow-up contacts)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
Study officials:
affiliation: University of California, San Francisco
name: Michael Nevitt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.