Status:
COMPLETED
Effect of Glucosamine on Joint Structure and Quality of Life (JOG)
Lead Sponsor:
University of Pittsburgh
Conditions:
Osteoarthritis
Eligibility:
All Genders
35-65 years
Phase:
NA
Brief Summary
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 ca...
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 devel...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT00377286
Start Date
September 1 2006
End Date
May 1 2008
Last Update
June 14 2011
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213