- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00833157
Effect of Glucosamine or Ibuprofen Combined With Physical Training in Patients With Knee-Osteoarthritis
January 29, 2009 updated by: Bispebjerg Hospital
The investigators will investigate the effect of glucosamine or ibuprofen combined with 12 weeks of muscle strength-training in patients with knee-osteoarthritis.
The investigators would like to elucidate whether treatment with glucosamine or NSAID interact with the effects of exercise in osteoarthritis patients.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 50 to 70 years
- Bilateral tibiofemoral osteoarthritis of the knee on x-ray
- American College of Rheumatology (ACR) clinical classification criteria
Exclusion Criteria:
- Severe health problems such as cardiovascular disease, active cancer, diabetes, kidney or liver diseases
- Excess alcohol use (> 21 alcoholic drinks per week)
- Severe overweight (BMI > 35)
- History of injury or operation in the knee, planned knee-joint replacement, other rheumatologic diseases, previous gastric ulcer, allergy to the contents of ibuprofen or glucosamine, regular strength training prior to the inclusion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
Subjects are administered placebo tablets, while they are performing a strength-training program (*3 weekly) with both legs for 12 weeks
|
EXPERIMENTAL: Glucosamine
|
Subjects are administered glucosamine-sulphate tablets of 500 mg * 3 daily, while they are performing a strength-training program with both legs (*3 weekly) for 12 weeks.
Other Names:
|
EXPERIMENTAL: Ibuprofen
|
Subjects are administered 600 mg * 2 daily, while they are performing a strength-training program with both legs (*3 weekly) for 12 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
muscle strength and hypertrophy
Time Frame: We measure before and after 12-weeks strength training.
|
We measure before and after 12-weeks strength training.
|
cartilage biomarkers
Time Frame: We measure before and after 12 weeks strength training
|
We measure before and after 12 weeks strength training
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
muscle regeneration and function
Time Frame: We measure before and after 12-weeks strength training.
|
We measure before and after 12-weeks strength training.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Susanne G Petersen, MD, Bispebjerg Hospital, Institute of Sports Medicine Copenhagen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Petersen SG, Beyer N, Hansen M, Holm L, Aagaard P, Mackey AL, Kjaer M. Nonsteroidal anti-inflammatory drug or glucosamine reduced pain and improved muscle strength with resistance training in a randomized controlled trial of knee osteoarthritis patients. Arch Phys Med Rehabil. 2011 Aug;92(8):1185-93. doi: 10.1016/j.apmr.2011.03.009.
- Petersen SG, Saxne T, Heinegard D, Hansen M, Holm L, Koskinen S, Stordal C, Christensen H, Aagaard P, Kjaer M. Glucosamine but not ibuprofen alters cartilage turnover in osteoarthritis patients in response to physical training. Osteoarthritis Cartilage. 2010 Jan;18(1):34-40. doi: 10.1016/j.joca.2009.07.004. Epub 2009 Jul 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Primary Completion (ACTUAL)
July 1, 2007
Study Completion (ANTICIPATED)
March 1, 2009
Study Registration Dates
First Submitted
January 29, 2009
First Submitted That Met QC Criteria
January 29, 2009
First Posted (ESTIMATE)
January 30, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
January 30, 2009
Last Update Submitted That Met QC Criteria
January 29, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Osteoarthritis, Knee
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ibuprofen
Other Study ID Numbers
- HIM-037
- KF-01-18904
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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