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

Primary Purpose

Osteoarthritis of the Knee

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
glucosamine sulphate
ibuprofen
placebo
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteoarthritis of the Knee focused on measuring Knee Osteoarthritis, exercise, strength training, Glucosamine, Dietary supplement, Ibuprofen, NSAID

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Glucosamine

    Ibuprofen

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    muscle strength and hypertrophy
    cartilage biomarkers

    Secondary Outcome Measures

    muscle regeneration and function

    Full Information

    First Posted
    January 29, 2009
    Last Updated
    January 29, 2009
    Sponsor
    Bispebjerg Hospital
    Collaborators
    Lund University, The Danish Rheumatism Association, Ministry of the Interior and Health, Denmark
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00833157
    Brief Title
    Effect of Glucosamine or Ibuprofen Combined With Physical Training in Patients With Knee-Osteoarthritis
    Official Title
    Effect of Glucosamine or Ibuprofen Combined With Physical Training in Patients With Knee-Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2005 (undefined)
    Primary Completion Date
    July 2007 (Actual)
    Study Completion Date
    March 2009 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis of the Knee
    Keywords
    Knee Osteoarthritis, exercise, strength training, Glucosamine, Dietary supplement, Ibuprofen, NSAID

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Glucosamine
    Arm Type
    Experimental
    Arm Title
    Ibuprofen
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    glucosamine sulphate
    Other Intervention Name(s)
    glucosamine from Ferrosan
    Intervention Description
    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
    Intervention Name(s)
    ibuprofen
    Other Intervention Name(s)
    "Ibumetin" from Nycomed (vnr:38 83 71)
    Intervention Description
    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
    Intervention Name(s)
    placebo
    Intervention Description
    Subjects are administered placebo tablets, while they are performing a strength-training program (*3 weekly) with both legs for 12 weeks
    Primary Outcome Measure Information:
    Title
    muscle strength and hypertrophy
    Time Frame
    We measure before and after 12-weeks strength training.
    Title
    cartilage biomarkers
    Time Frame
    We measure before and after 12 weeks strength training
    Secondary Outcome Measure Information:
    Title
    muscle regeneration and function
    Time Frame
    We measure before and after 12-weeks strength training.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Susanne G Petersen, MD
    Organizational Affiliation
    Bispebjerg Hospital, Institute of Sports Medicine Copenhagen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21807137
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    19679221
    Citation
    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.
    Results Reference
    derived

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

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