NCT00833157

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2005

Longer than P75 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 30, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

January 30, 2009

Status Verified

January 1, 2009

Enrollment Period

2.4 years

First QC Date

January 29, 2009

Last Update Submit

January 29, 2009

Conditions

Osteoarthritis of the Knee

Keywords

Knee Osteoarthritisexercisestrength trainingGlucosamineDietary supplementIbuprofenNSAID

Outcome Measures

Primary Outcomes (2)

  • muscle strength and hypertrophy

    We measure before and after 12-weeks strength training.

  • cartilage biomarkers

    We measure before and after 12 weeks strength training

Secondary Outcomes (1)

  • muscle regeneration and function

    We measure before and after 12-weeks strength training.

Study Arms (3)

Glucosamine

EXPERIMENTAL
Drug: glucosamine sulphate

Ibuprofen

EXPERIMENTAL
Drug: ibuprofen

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

glucosamine sulphateDRUG

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.

Also known as: glucosamine from Ferrosan
Glucosamine
ibuprofenDRUG

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

Also known as: "Ibumetin" from Nycomed (vnr:38 83 71)
Ibuprofen
placeboDRUG

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

Placebo

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50 to 70 years
  • Bilateral tibiofemoral osteoarthritis of the knee on x-ray
  • American College of Rheumatology (ACR) clinical classification criteria

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 21807137DERIVED

  • 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.

    PMID: 19679221DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeMotor Activity

Interventions

GlucosamineIbuprofen

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

HexosaminesAmino SugarsCarbohydratesPhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Susanne G Petersen, MD

    Bispebjerg Hospital, Institute of Sports Medicine Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 29, 2009

First Posted

January 30, 2009

Study Start

February 1, 2005

Primary Completion

July 1, 2007

Study Completion

March 1, 2009

Last Updated

January 30, 2009

Record last verified: 2009-01