Effect of Glucosamine on Joint Structure and Quality of Life (JOG)

Completed · Not applicable

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT00377286

Run by

University of Pittsburgh

People needed

201

Starts

2006-09-01

Expected to finish

2008-05-01

Last updated by the study team

2011-06-14

Who can join

Age: 35 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.