Effect of Glucosamine on Joint Structure and Quality of Life (JOG) - Full Text View

Sponsored by:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00377286

Purpose

The goal of this study is 1) to develop a biomarker of of cartilage synthesis by determining if there is a relationship between changes in the status of knee cartilage and the amount of a biomarker called CTX-II in urine. 2) We will also characterize people who have experienced cartilage loss and/or reduced functional ability using performance tests and a questionnaire. 3) The administration of glucosamine in a beverage for six months will be used to promote the alteration in cartilage status and improve function in people with mild to moderate joint pain. A secondary goal will be to assess the effect of glucosamine on the skin in a small subset of women.

Condition	Intervention
Osteoarthritis	Dietary Supplement: Glucosamine (a dietary supplement) Other: 16 oz lite lemonade

MedlinePlus related topics: Dietary Supplements Osteoarthritis

Drug Information available for: Glucosamine Glucosamine hydrochloride Glucosamine sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	Development of Biomarker and Functional Assessment Tools to Evaluate the Effect of Glucosamine on Joint Structure and Quality of Life

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Urinary excretion of CTX-II at 3 and 6 months post intervention [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
Measurement of bone marrow lesions, cartilage volume, as shown by MRI at 6 months post intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Scores on WOMAC and KOOS of knee pain and function [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
Scores on performance measures [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Measures of skin hydration and structure [ Time Frame: 6 and 12 wks ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	September 2006
Estimated Study Completion Date:	June 2008

Arms	Assigned Interventions
2: Placebo Comparator 1500 mg of lite lemonade	Other: 16 oz lite lemonade 16 oz lite lemonade 1 time daily for 6 months
1: Active Comparator 1500 mg glucosamine in 16 oz lite lemonade 1 time daily for 6 months	Dietary Supplement: Glucosamine (a dietary supplement) 1500 mg in 16 oz lite lemonade, once per day for 6 months

Detailed Description:

Reduced knee function is a significant cause of physical limitations and disability. As cartilage deteriorates due to aging, wear-and-tear, injury, or disease, joint space narrowing and pain can develop. The lost of articular cartilage arises from an imbalance between cartilage synthesis and cartilage degradation. When cartilage needs to be remodeled, enzymes such as matrix metalloproteinases (MMPs) degrade type II collagen. It now may be possible to use new molecular markers of cartilage degradation to assess the progression of joint loss in comparison with radiographic changes of the knee joint. Urinary excretion of C-terminal cross linking telopeptide of type II collagen (CTX-II) is a new molecular marker of cartilage tissue degradation metabolism.

Recent evidence suggests that glucosamine, a dietary supplement, may provide some relief from joint pain and may increase the functional ability to participate in activities of daily living. This may be a result of these dietary supplements stimulating tissue repair such as cartilage in the affected joints, or by inhibiting the degradation of cartilage through an inhibition of enzymes. Moreover, Braham, Dawson, & Goodman (2003) reported increases in function in adults with knee pain following 12 -weeks of glucosamine supplementation. It is unclear, however, if glucosamine delivered via a liquid carrier would improve physical function and impact quality of life measures in people who have experienced loss of knee cartilage.

Glucosamine is a precursor for glycosaminoglycans, which are a major component of both joint cartilage and skin. Potential benefits of glucosamine on skin have been reported previously. It is possible that glucosamine in a beverage might also improve skin parameters over time.

Comparisons: 100 men and women with mild to moderate joint pain taking a liquid with glucosamine, compared to 100 men and women with mild to moderate joint pain taking a liquid with placebo.

Eligibility

Ages Eligible for Study:	35 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female or male (female only for skin sub-study)
35-65 years of age (40 -65 for skin sub-study)
Willingness to provide informed consent
Willingness to be randomized to glucosamine or placebo
Knee pain on more days than not for at least one month in past year
Sum of WOMAC pain subscales between 300 and 500 inclusive
Ability to read and understand English
Ability to understand study procedures
Dry skin for sub-study

Exclusion Criteria:

Plans for elective surgery in the next 12 months Plans to move out of the area in the next 12 months
Concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy including inflammatory arthritis
Spine or hip pain of sufficient magnitude to interfere with the evaluation of the knee
Isolated patellofemoral disease manifested by primarily anterior knee pain in the absence of tibiofemoral radiographic finding
History of arthroscopy of the affected knee within 6 months prior to study entry
Allergy to,or history of significant clinical or laboratory adverse experience associated with acetaminophen or glucosamine
Inability to undergo a MRI of knee
Inability to walk without a cane or other assistive device
Liver or kidney disease
Diabetes mellitus
Women who are currently pregnant or nursing, pregnant within the previous six months, or planning on becoming pregnant within the next 6 months
Unwilling to use double barrier method of contraception
Alcohol use in excess of 3 mixed drinks/day
Corticosteroid treatment
Sustained use of NSAIDS including aspirin in anti-inflammatory doses may be used for treatment of pain other than knee pain, if such use is intermittent
Topical analgesics
Other medical therapy for arthritis within one month prior to entry
Participation in another clinical study with an investigational agent within the last 4 weeks
Have taken glucosamine in past 3 months, chondroitin, Sam-E, MSM or other dietary supplements for knee pain within the past 6 months
Have taken a bisphosphonate medication that affects bone turnover in the past 6 months
Initiation of physical therapy or muscle conditioning program within 2 months prior to study entry
Intra-articular injection of hyaluronic acid or congeners into the knee within past 12 months.
Concurrent use of tetracycline, anticoagulants, dietary supplements or other complementary or alternative regimens for joint pain
History of knee or hip replacement
Weight exceeds 285 in men or 250 in women.
Have had any of the following cancers: Acute Leukemia, Brain, Chronic Leukemia, Esophagus, Liver,Lung, Lymphoma, Multiple Myeloma, Pancreas, Skin Melanoma, and Stomach.
Have taken any of the following doctor prescribed medications for arthritis: Methotrexate, Plaquenil, Hydroxychloroquine, Enbrel, Etanercept, Remicade, Infliximab, Arava, Leflunomide, Gold shots or pills, Prednisone pills, steroid pills, or glucocorticoid pills taken by mouth, Sulfasalazine, Kineret, Anakinra, Humira, and Adalimumab.
Kellgren-Lawrence score of 4 (severe) in both knees based on x-ray.
Anterior knee pain only with normal x-ray results.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377286

Locations

United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Investigators

Principal Investigator:	John Jakicic, PhD	University of Pittsburgh
Principal Investigator:	C. Kent Kwoh, M.D.	University of Pittsburgh

More Information

Responsible Party:	University of Pittsburgh ( John Jakicic, PhD )
Study ID Numbers:	0604099
Study First Received:	September 14, 2006
Last Updated:	December 12, 2007
ClinicalTrials.gov Identifier:	NCT00377286
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Osteoarthritis
Knee Pain
Glucosamine
MRI

CTX-II
Biomarkers
Skin quality

Study placed in the following topic categories:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis

Quality of Life
Pain
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 15, 2009