OsteoarthritisNCT00377286
Effect of Glucosamine on Joint Structure and Quality of Life (JOG)
A study testing Glucosamine (a dietary supplement) and 16 oz lite lemonade in people with Osteoarthritis, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Glucosamine (a dietary supplement) and 16 oz lite lemonade
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Ability to read and understand English
- Ability to understand study procedures
- Dry skin for sub-study
Who cannot join
- 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
Show all 29Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Development of Biomarker and Functional Assessment Tools to Evaluate the Effect of Glucosamine on Joint Structure and Quality of Life
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Glucosamine (a dietary supplement), 16 oz lite lemonade
- Keywords
- Osteoarthritis, Knee Pain, Glucosamine, MRI, CTX-II, Biomarkers, Skin quality
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucosamine (a dietary supplement)Dietary supplement
1500 mg in 16 oz lite lemonade, once per day for 6 months
16 oz lite lemonadeOther
Also called Minute Maid
16 oz lite lemonade 1 time daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | 1500 mg of lite lemonade Receives: Other: 16 oz lite lemonade |
| 1 | Active comparator | 1500 mg glucosamine in 16 oz lite lemonade 1 time daily for 6 months Receives: Dietary Supplement: Glucosamine (a dietary supplement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary excretion of CTX-II at 3 and 6 months post intervention
Measured: 3 and 6 months
Measurement of bone marrow lesions, cartilage volume, as shown by MRI post intervention
Measured: 6 month
Secondary outcomes (2)
Scores on WOMAC and KOOS of knee pain and function
Measured: 3 and 6 months
Scores on performance measures
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Investigators
- John Jakicic, PhD, Principal investigator, University of PittsburghC. Kent Kwoh, M.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377286
- Sponsor's protocol ID
- 0604099
- Status last verified
- Jun 2011
- First submitted
- 14 Sep 2006
- Last updated
- 14 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24616448Roemer 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.
PubMed 22213129
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Biomarker and Functional Assessment Tools to Evaluate the Effect of Glucosamine on Joint Structure and Quality of Life
- ClinicalTrials.gov ID
- NCT00377286
- Acronym / sponsor ID
- 0604099
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Knee Pain, Glucosamine, MRI, CTX-II, Biomarkers, Skin quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 18 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Other: 16 oz lite lemonade1500 mg of lite lemonade |
| 1 | Active comparator | Dietary Supplement: Glucosamine (a dietary supplement)1500 mg glucosamine in 16 oz lite lemonade 1 time daily for 6 months |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucosamine (a dietary supplement)1500 mg in 16 oz lite lemonade, once per day for 6 months | Dietary supplement | 1 |
| 16 oz lite lemonadeAlso: Minute Maid16 oz lite lemonade 1 time daily for 6 months | Other | 2 |
Primary outcome
Urinary excretion of CTX-II at 3 and 6 months post intervention
Time frame: 3 and 6 months
Measurement of bone marrow lesions, cartilage volume, as shown by MRI post intervention
Time frame: 6 month
2 secondary outcomes
Scores on WOMAC and KOOS of knee pain and function
Time frame: 3 and 6 months
Scores on performance measures
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2011.
- Derived from this study: PubMed 24616448Kwoh 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.
- Derived from this study: PubMed 22213129Roemer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Jakicic, PhD principal investigator
University of Pittsburgh
C. Kent Kwoh, M.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucosamine (a dietary supplement) and 16 oz lite lemonade in people with Osteoarthritis, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary excretion of CTX-II at 3 and 6 months post intervention (time frame: 3 and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00377286, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2011.