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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 because the information has not been verified recently.
Verified January 2009 by Bispebjerg Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Lund University
The Danish Rheumatism Association
Ministry of the Interior and Health, Denmark
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00833157
First received: January 29, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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. ] [ Designated as safety issue: No ]
  • cartilage biomarkers [ Time Frame: We measure before and after 12 weeks strength training ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • muscle regeneration and function [ Time Frame: We measure before and after 12-weeks strength training. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Bispebjerg Hospital

Additional 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
Study First Received: January 29, 2009
Last Updated: January 29, 2009
Health Authority: Denmark: Ethics Committee

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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013