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

NCT ID: NCT00833157

Last Updated: 2009-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis of the Knee

Keywords

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Knee Osteoarthritis exercise strength training Glucosamine Dietary supplement Ibuprofen NSAID

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Glucosamine

Group Type EXPERIMENTAL

glucosamine sulphate

Intervention Type DRUG

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

Group Type EXPERIMENTAL

ibuprofen

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Subjects are administered placebo tablets, while they are performing a strength-training program (\*3 weekly) with both legs for 12 weeks

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

placebo

Subjects are administered placebo tablets, while they are performing a strength-training program (\*3 weekly) with both legs for 12 weeks

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lund University

OTHER

Sponsor Role collaborator

The Danish Rheumatism Association

OTHER

Sponsor Role collaborator

Ministry of the Interior and Health, Denmark

OTHER_GOV

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Denmark

Principal Investigators

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Susanne G Petersen, MD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital, Institute of Sports Medicine Copenhagen

References

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Petersen SG, Beyer N, Hansen M, Holm L, Aagaard P, Mackey AL, Kjaer M. Nonsteroidal anti-inflammatory drug or glucosamine reduced pain and improved muscle strength with resistance training in a randomized controlled trial of knee osteoarthritis patients. Arch Phys Med Rehabil. 2011 Aug;92(8):1185-93. doi: 10.1016/j.apmr.2011.03.009.

Reference Type DERIVED
PMID: 21807137 (View on PubMed)

Petersen SG, Saxne T, Heinegard D, Hansen M, Holm L, Koskinen S, Stordal C, Christensen H, Aagaard P, Kjaer M. Glucosamine but not ibuprofen alters cartilage turnover in osteoarthritis patients in response to physical training. Osteoarthritis Cartilage. 2010 Jan;18(1):34-40. doi: 10.1016/j.joca.2009.07.004. Epub 2009 Jul 15.

Reference Type DERIVED
PMID: 19679221 (View on PubMed)

Other Identifiers

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KF-01-18904

Identifier Type: -

Identifier Source: secondary_id

HIM-037

Identifier Type: -

Identifier Source: org_study_id