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

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:
  • glucosamine from Ferrosan
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:
  • "Ibumetin" from Nycomed (vnr:38 83 71)

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.

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.

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

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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