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

Osteoarthritis of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00833157
• Other study ID #: HIM-037
• Secondary ID: KF-01-18904
• Status: Active, not recruiting
• Phase: Phase 1
• First received: January 29, 2009
• Last updated: January 29, 2009
• Start date: February 2005
• Est. completion date: March 2009

Study information

• Verified date: January 2009
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: March 2009
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

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.
• ibuprofen
Subjects are administered 600 mg * 2 daily, while they are performing a strength-training program with both legs (*3 weekly) for 12 weeks
• placebo
Subjects are administered placebo tablets, while they are performing a strength-training program (*3 weekly) with both legs for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Lund University, Ministry of the Interior and Health, Denmark, The Danish Rheumatism Association

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle strength and hypertrophy		We measure before and after 12-weeks strength training.	No
Primary	cartilage biomarkers		We measure before and after 12 weeks strength training	No
Secondary	muscle regeneration and function		We measure before and after 12-weeks strength training.	No