The University of California, San Francisco is one of nine centers selected for a nationwide clinical study on the effectiveness of two natural substances in treating osteoarthritis of the knee.
A four-year, $6.6 million grant from the National Institutes of Health will fund the multi-center study. The project will evaluate medications that duplicate the properties of glucosamine and chondroitin sulfate, which are found naturally in and around the cells of cartilage, the connective tissue that cushions the ends of bones within the joint.
If the medications produce good results, they have the potential for helping some 21 million Americans with osteoarthritis who live with chronic pain in their joints and with limited motion, according to Nancy Lane, MD, principal investigator for the UCSF study site.
"Millions of people with osteoarthritis are taking these two substances in the form of dietary supplements obtained from local drugstores and health food stores to combat the joint pain that they have from this disease. This study is important because we will find out if these substances really work," said Lane, a UCSF associate professor of medicine who treats patients at San Francisco General Hospital Medical Center.
The national study is expected to involve more than 1,000 patients with knee osteoarthritis. It is approved as a Phase III, randomized, double-blind trial to test the efficacy, safety and side effects of the two substances. The medications will be administered to patients orally.
The trial will consist of four arms: (1) patients taking glucosamine alone, (2) patients taking chondroitin sulfate alone, (3) patients taking glucosamine and chondroitin sulfate together, and (4) patients taking a placebo.
Patients will be evaluated at monthly intervals for 16 weeks and closely monitored for improvement of their osteoarthritis as well as for any possible adverse reactions to the medications. Medical evaluations and x-rays will be used to document a patient diagnosis. Outcome will be measured by improvement in pain and function.
Osteoarthritis, also known as OA and degenerative joint disease, is caused by a breakdown of cartilage. It generally occurs later in life and most commonly affects the hands and large weight-bearing joints, such as the knee. Age, female gender, and obesity are risk factors for knee OA, which is associated with progressive reduction in function and a decrease in mobility, including difficulty in changing from a sitting to a standing position.
The University of Utah School of Medicine is the coordinating center for the national study. In addition to Utah and UCSF, the other study centers are Arthritis Research and Clinical Centers, Wichita; Case Western Reserve University, Cleveland; University of California, San Diego; Indiana University School of Medicine, Indianapolis; University of Nebraska Rheumatology Network, Omaha; University of Pennsylvania School of Medicine, Philadelphia; and Virginia Mason Medical Center, Seattle.
The NIH grant that is funding the trial was awarded through the National Center for Complementary and Alternative Medicine (NCCAM) in collaboration with the National Institutes of Arthritis and Musculoskeletal and Skin Diseases.
In January 1998, NCCAM convened a group of scientists to discuss the need, rationale, and feasibility of conducting a Phase III study on glucosamine and chondroitin sulfate, and the group determined that there was a need to test the two substances.
Various formulations of these substances have been marketed and sold as alternative approaches to pain control in the form of nutritional or dietary supplements. Several new books also have promoted the substances as effective treatments for arthritis.
Patient recruitment is expected to begin in about six months; however, interested patients in the Bay Area can contact Dr. Lane now with their names and call-back phone numbers. She can be reached at (415) 206-6654 or by email at: nelane@itsa.ucsf.edu . Follow-up with prospective study participants will be made in the spring.