Overview

This trial is active, not recruiting.

Condition osteoarthritis of the knee
Treatments glucosamine sulphate, ibuprofen, placebo
Phase phase 1
Sponsor Bispebjerg Hospital
Collaborator Lund University
Start date February 2005
End date July 2007
Trial size 36 participants
Trial identifier NCT00833157, HIM-037, KF-01-18904

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Experimental)
glucosamine sulphate glucosamine from Ferrosan
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.
(Experimental)
ibuprofen "Ibumetin" from Nycomed (vnr:38 83 71)
Subjects are administered 600 mg * 2 daily, while they are performing a strength-training program with both legs (*3 weekly) for 12 weeks
(Placebo Comparator)
placebo
Subjects are administered placebo tablets, while they are performing a strength-training program (*3 weekly) with both legs for 12 weeks

Primary Outcomes

Measure
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 Outcomes

Measure
muscle regeneration and function
time frame: We measure before and after 12-weeks strength training.

Eligibility Criteria

Male or female participants from 50 years up to 70 years old.

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

Additional Information

Official title Effect of Glucosamine or Ibuprofen Combined With Physical Training in Patients With Knee-Osteoarthritis
Principal investigator Susanne G Petersen, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2009.
Information provided to ClinicalTrials.gov by Bispebjerg Hospital.