TOPS Clinical Trial

TOPS (The Osteoarthritis Prevention Study) is a randomized clinical trial supported by the Arthritis Foundation. Its purpose is to find whether diet and exercise can help women over 50 reduce their risk of knee osteoarthritis, a leading cause of disability.

Trial Overview

The Osteoarthritis Prevention Study (TOPS), supported by the Arthritis Foundation, is a four-year clinical trial testing whether a structured program of dietary weight loss, exercise and weight-loss maintenance can prevent knee osteoarthritis (OA) in women aged 50 and older with obesity. The study will enroll women who do not yet show signs of knee OA. Researchers will monitor joint changes using MRI and measures of pain, mobility, inflammation, quality of life and cost-effectiveness to understand the program's full impact. If successful, TOPS could offer a primary intervention to prevent the development of knee OA, a common joint disease with no current cure.

What type of study is the TOPS trial?

TOPS is a multicenter, randomized clinical trial. Participants are randomly assigned to either the structured program group or a health education group. Researchers will follow all participants for four years to track joint changes, pain, mobility and overall health.

Can diet and exercise really prevent knee osteoarthritis?

While diet and exercise are known to help manage symptoms in people with an osteoarthritis diagnosis, the TOPS trial is one of the first large studies testing whether they can prevent knee osteoarthritis from developing in the first place. If successful, this could change how we approach OA — focusing on prevention rather than just treatment.

Are there risks associated with the study?

As with any study involving physical activity and dietary changes, there may be some minor risks — such as muscle soreness, fatigue or injury during exercise. All programs are supervised by trained professionals, and participants are carefully monitored throughout the study. The trial is designed with participant safety as a top priority.

What happens when a patient is enrolled?

Once enrolled, participants are randomly assigned to one of two groups: a diet and exercise group or a health education group. They attend regular classes focused either on weight loss and physical activity or on general health information. Throughout the study, participants will have check-ins, physical assessments and MRI scans to monitor their joint health, mobility and overall well-being.

For Providers:
National Clinical Trial No. for the TOPS clinical trial
NCT05946044

For more information about the TOPS trial, visit ClinicalTrials.gov.

Scientific Publications

TOPS Presentation

Stephen P. Messier, PhD, principal investigator of the multi-center The Osteoarthritis Prevention Study (TOPS) clinical trial and Professor and Director of the J.B Snow Biomechanics Laboratory at Wake Forest University, shares a technical overview of the TOPS trial and its progress. Check back for updates.

Download Presentation

TOPS Trial

Rationale & Design

This manuscript outlines the rationale, study design and implementation of the TOPS trial, which is a primary prevention intervention trial of dietary weight loss, exercise, and weight-loss maintenance for women at risk for the development of knee osteoarthritis.

Read Manuscript

Clinical Trial Sites

Wake Forest University, Winston-Salem, NC
- Principal Investigator: Stephen Messier, PhD
- Site Principal Investigator: Shannon Mihalko, PhD
- Data Coordinating Center: Edward Ip, PhD
Brigham and Women's Hospital, Boston, MA
- Site Principal Investigator: Elena Losina, PhD, MSc
University of North Carolina at Chapel Hill, Chapel Hill, NC
- Site Principal Investigator: Leigh Callahan, PhD
University of Sydney, Sydney, Australia
- Site Principal Investigator: David Hunter, MBBS, PhD, MSc
University of Missouri, Columbia, MO
- Data Coordinating Center: Jimi Cook, DVM, PhD, OTSC

More About TOPS

TOPS is the first study in the United States to examine weight loss and exercise as preventatives for osteoarthritis.

PIKASO Clinical Trial

PIKASO is a collaborative, randomized clinical trial testing whether metformin can slow or prevent osteoarthritis progression in people with major knee injuries.

Get the Study Details

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