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Effect of Glucosamine or Ibuprofen Combined With Physical Training in Patients With Knee-Osteoarthritis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Bispebjerg Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00833157
First Posted: January 30, 2009
Last Update Posted: January 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Lund University
The Danish Rheumatism Association
Ministry of the Interior and Health, Denmark
Information provided by:
Bispebjerg Hospital
  Purpose

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.


Condition Intervention Phase
Osteoarthritis of the Knee Drug: glucosamine sulphate Drug: ibuprofen Drug: placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Glucosamine or Ibuprofen Combined With Physical Training in Patients With Knee-Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • muscle strength and hypertrophy [ Time Frame: We measure before and after 12-weeks strength training. ]
  • cartilage biomarkers [ Time Frame: We measure before and after 12 weeks strength training ]

Secondary Outcome Measures:
  • muscle regeneration and function [ Time Frame: We measure before and after 12-weeks strength training. ]

Enrollment: 36
Study Start Date: February 2005
Estimated Study Completion Date: March 2009
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glucosamine Drug: glucosamine sulphate
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 Name: glucosamine from Ferrosan
Experimental: Ibuprofen Drug: 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 Name: "Ibumetin" from Nycomed (vnr:38 83 71)
Placebo Comparator: Placebo Drug: placebo
Subjects are administered placebo tablets, while they are performing a strength-training program (*3 weekly) with both legs for 12 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833157


Sponsors and Collaborators
Bispebjerg Hospital
Lund University
The Danish Rheumatism Association
Ministry of the Interior and Health, Denmark
Investigators
Principal Investigator: Susanne G Petersen, MD Bispebjerg Hospital, Institute of Sports Medicine Copenhagen
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Susanne G. Petersen, doctor, Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Denmark
ClinicalTrials.gov Identifier: NCT00833157     History of Changes
Other Study ID Numbers: HIM-037
KF-01-18904
First Submitted: January 29, 2009
First Posted: January 30, 2009
Last Update Posted: January 30, 2009
Last Verified: January 2009

Keywords provided by Bispebjerg Hospital:
Knee Osteoarthritis
exercise
strength training
Glucosamine
Dietary supplement
Ibuprofen
NSAID

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action