Alice Trinkl, News Director
source: Corinna Kaarlela
ckaarlela@pubaff.ucsf.edu
for immediate release
November 19, 1999
UCSF NAMED ON ONE OF NINE CENTERS FOR NIH STUDY ON TREATMENT FOR KNEE OSTEOARTHRITIS
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.
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