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

NCT00377286 | Completed DMC

• 1 other identifier: 0604099
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Osteoarthritis

Keywords

Osteoarthritis; Knee Pain; Glucosamine; MRI; CTX-II; Biomarkers; Skin quality

Outcome Measures

Primary Outcomes (2)

• Urinary excretion of CTX-II at 3 and 6 months post intervention

  3 and 6 months

• Measurement of bone marrow lesions, cartilage volume, as shown by MRI post intervention

  6 month

Secondary Outcomes (2)

• Scores on WOMAC and KOOS of knee pain and function

  3 and 6 months

• Scores on performance measures

  6 months

Study Arms (2)

2

PLACEBO COMPARATOR

1500 mg of lite lemonade

Other: 16 oz lite lemonade

1

ACTIVE COMPARATOR

1500 mg glucosamine in 16 oz lite lemonade 1 time daily for 6 months

Dietary Supplement: Glucosamine (a dietary supplement)

Interventions

Glucosamine (a dietary supplement) DIETARY_SUPPLEMENT

1500 mg in 16 oz lite lemonade, once per day for 6 months

1

16 oz lite lemonade OTHER

16 oz lite lemonade 1 time daily for 6 months

Also known as: Minute Maid

2

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male (female only for skin sub-study)
• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• Kwoh CK, Roemer FW, Hannon MJ, Moore CE, Jakicic JM, Guermazi A, Green SM, Evans RW, Boudreau R. Effect of oral glucosamine on joint structure in individuals with chronic knee pain: a randomized, placebo-controlled clinical trial. Arthritis Rheumatol. 2014 Apr;66(4):930-9. doi: 10.1002/art.38314.

  PMID: 24616448 DERIVED

• Roemer FW, Kwoh CK, Hannon MJ, Green SM, Jakicic JM, Boudreau R, Crema MD, Moore CE, Guermazi A. Risk factors for magnetic resonance imaging-detected patellofemoral and tibiofemoral cartilage loss during a six-month period: the joints on glucosamine study. Arthritis Rheum. 2012 Jun;64(6):1888-98. doi: 10.1002/art.34353. Epub 2011 Dec 27.

  PMID: 22213129 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Glucosamine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hexosamines; Amino Sugars; Carbohydrates

Study Officials

• John Jakicic, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• C. Kent Kwoh, M.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2006
• First Posted: September 18, 2006
• Study Start: September 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: June 14, 2011

Record last verified: 2011-06

Locations

US (1)