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Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT) Begins Patient Recruitment

NIH News Release

National Institutes of Health

National Center for Complementary and Alternative Medicine (NCCAM)

For immediate release:

Monday, December 11, 2000

Please see Questions & Answers: NIH Glucosamine/Chondroitin Arthritis Intervention Trial for updated information.

Updated May 2002

Bethesda, Maryland—The first U.S. multicenter study to investigate glucosamine and chondroitin, two dietary supplements widely marketed in the United States as effective natural remedies for osteoarthritis (OA), is about to begin. In September 1999, the National Center for Complementary and Alternative Medicine (NCCAM) in collaboration with the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) announced a contract award to the University of Utah to determine conclusively whether glucosamine or chondroitin are more effective than placebo for treating knee pain associated with OA. The study is now enrolling participants.

This study, totaling $14 million, will also determine whether the combination of these two substances is more effective than glucosamine or chondroitin alone. "Only a few rather small studies have been published in the worldwide literature, to-date," according to Stephen E. Straus, M.D., NCCAM Director. "Those short-term, controlled clinical trials suggested that glucosamine is effective in relieving pain and increasing range of motion in patients with osteoarthritis. This major new study will provide compelling answers to the nearly 40 million Americans who suffer with osteoarthritis about the safety and effectiveness of glucosamine and/or chondroitin," Dr. Straus added.

Since the contract was awarded, protocol development has been completed so that the study—now called the Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)--will proceed. The study investigators held a "kick-off" meeting September 27-29, 2000.

The ambitious study will be a 24-week placebo-controlled, parallel, double blind, five-arm clinical trial. A total of 1,588 individuals will be enrolled in the study at 13 clinical centers. The efficacy of glucosamine alone, chondroitin alone, and the combination of glucosamine and chondroitin will be compared to placebo in treating knee pain of osteoarthritis (OA). Moreover, in order to verify that the study is able to detect significant treatment effects, celecoxib—an established effective conventional treatment for OA will also be compared to placebo. Patients will be able to take acetaminophen if they experience severe pain.

The study will be conducted in three phases. Phase I of the study has already been completed. This phase involved refining the study design, hiring personnel, developing operating policies and procedures, testing the electronic data entry system, obtaining local Institute Review Board (IRB) approvals, and securing the Investigational New Drug (IND) exemption for the study from the Food and Drug Administration. Phase II is the enrollment and treatment phase, which will take approximately 33 months. During this phase patients will be recruited and evaluated, study data will be checked for errors and completeness, and reports will be prepared on patient recruitment, the status of data collection, and quality control. Phase III is expected to last 6 months, which will include data clean-up, analysis, and preparation of the final report due in March 2005.

To thoroughly evaluate whether these substances impact the progression of knee OA, an additional study or "sub-study" has been added to the primary GAIT trial. In this sub-study, approximately one-half of patients enrolled in the primary GAIT trial will receive blinded treatment (whereby patients do not know the specific treatment they receive) for an additional 18 months. Specially positioned knee radiographs will be obtained at the beginning of the study and after 1 and 2 years of treatment. These films will be compared and evaluated for any structural change among the five groups. Two-year clinical efficacy and safety data will also be collected. This sub-study is jointly funded by NCCAM and NIAMS.

Daniel O. Clegg, M.D, Professor of Medicine and Chief of the Division of Rheumatology, University of Utah School of Medicine, will direct the coordinating center, which will oversee the research, patient recruitment, and data collection efforts of 13 study centers across the country.

The participating 13 GAIT study centers, principal investigators, and study coordinators contact numbers are as follows:

The Biostatistical Center is located at the VA Hospital, Hines, IL (Domenic Reda, M.S.), and The Pharmacy Center at the VA Medical Center, Albuquerque, NM (Carol Fye, R.Ph., M.S.) will also be involved in the study.

The glucosamine hydrochloride used in this study is manufactured by Pfanstiehl Laboratories located in Waukegan, IL, and donated by Wilke Resources. The chondroitin sulfate is manufactured and donated by Bioiberica, S.A., located in Barcelona, Spain. Open-label acetaminophen 500 mg capsules, donated by McNeil Consumer Healthcare, will also be provided to each center.

For information regarding patient recruitment, please contact the study center closest to you.

The National Center for Complementary and Alternative Medicine (NCCAM) is dedicated to exploring complementary and alternative medical (CAM) practices in the context of rigorous science, training CAM researchers and disseminating authoritative information. For additional information about NCCAM, please visit our Web site.