NCT01074476

Brief Summary

Osteoarthritis (OA) is the most common joint disease associated with aging. Although many patients take glucosamine supplements as a non-traditional treatment for osteoarthritis, the effectiveness of these supplements is questionable. This study will evaluate glucosamine therapy by directly analyzing two functions of joint fluid that are impaired by osteoarthritis - namely, the abilities to lubricate the joint and absorb shocks during activity. Joint fluid samples will be collected from subjects with knee osteoarthritis and analyzed on a device that simulates typical joint movements. After 3 months of glucosamine supplementation, samples will be collected again to detect potential improvements in joint fluid function.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

February 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
5.3 years until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 29, 2016

Status Verified

June 1, 2016

Enrollment Period

2 years

First QC Date

February 22, 2010

Last Update Submit

June 28, 2016

Conditions

Keywords

Knee osteoarthritisglucosaminesynovial fluidviscosityviscoelasticityWOMAC

Outcome Measures

Primary Outcomes (1)

  • Changes in synovial fluid viscosity and viscoelasticity compared to baseline

    3 months

Secondary Outcomes (1)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score

    3 months

Study Arms (2)

1

EXPERIMENTAL

Glucosamine sulphate tablets

Dietary Supplement: Glucosamine sulphate

2

PLACEBO COMPARATOR

Placebo tablets

Other: Placebo

Interventions

Glucosamine sulphateDIETARY_SUPPLEMENT

750mg glucosamine sulphate (oral tablets), twice per day for 3 months

1
PlaceboOTHER

Placebo tablets, twice per day for 3 months

2

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • are between 30 and 85 years of age
  • are clinically diagnosed with moderate to severe knee OA
  • are recommended for synovial fluid aspiration

You may not qualify if:

  • are clinically diagnosed with inflammatory arthritis
  • had previous joint surgery in the study knee
  • had injection in the study knee within the past 12 months
  • have taken glucosamine and/or chondroitin supplements within the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

OASIS Vancouver Clinic, Gordon & Leslie Diamond Health Care Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

University of British Columbia Health Clinic

Vancouver, British Columbia, V6T 1Z3, Canada

Location

Related Publications (7)

  • Fam H, Bryant JT, Kontopoulou M. Rheological properties of synovial fluids. Biorheology. 2007;44(2):59-74.

    PMID: 17538199BACKGROUND
  • Anadere I, Chmiel H, Laschner W. Viscoelasticity of "normal" and pathological synovial fluid. Biorheology. 1979;16(3):179-84. doi: 10.3233/bir-1979-16306. No abstract available.

    PMID: 508928BACKGROUND
  • Schurz J, Ribitsch V. Rheology of synovial fluid. Biorheology. 1987;24(4):385-99. doi: 10.3233/bir-1987-24404.

    PMID: 3663897BACKGROUND
  • Vangsness CT Jr, Spiker W, Erickson J. A review of evidence-based medicine for glucosamine and chondroitin sulfate use in knee osteoarthritis. Arthroscopy. 2009 Jan;25(1):86-94. doi: 10.1016/j.arthro.2008.07.020. Epub 2008 Sep 30.

    PMID: 19111223BACKGROUND
  • Black C, Clar C, Henderson R, MacEachern C, McNamee P, Quayyum Z, Royle P, Thomas S. The clinical effectiveness of glucosamine and chondroitin supplements in slowing or arresting progression of osteoarthritis of the knee: a systematic review and economic evaluation. Health Technol Assess. 2009 Nov;13(52):1-148. doi: 10.3310/hta13520.

    PMID: 19903416BACKGROUND
  • Clegg DO, Reda DJ, Harris CL, Klein MA, O'Dell JR, Hooper MM, Bradley JD, Bingham CO 3rd, Weisman MH, Jackson CG, Lane NE, Cush JJ, Moreland LW, Schumacher HR Jr, Oddis CV, Wolfe F, Molitor JA, Yocum DE, Schnitzer TJ, Furst DE, Sawitzke AD, Shi H, Brandt KD, Moskowitz RW, Williams HJ. Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis. N Engl J Med. 2006 Feb 23;354(8):795-808. doi: 10.1056/NEJMoa052771.

    PMID: 16495392BACKGROUND
  • Matsuno H, Nakamura H, Katayama K, Hayashi S, Kano S, Yudoh K, Kiso Y. Effects of an oral administration of glucosamine-chondroitin-quercetin glucoside on the synovial fluid properties in patients with osteoarthritis and rheumatoid arthritis. Biosci Biotechnol Biochem. 2009 Feb;73(2):288-92. doi: 10.1271/bbb.80418. Epub 2009 Feb 7.

    PMID: 19202302BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Glucosamine

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

HexosaminesAmino SugarsCarbohydrates

Study Officials

  • Ezra Kwok, Dr

    University of British Columbia

    PRINCIPAL INVESTIGATOR
  • Dana Grecov, Dr.

    University of British Columbia

    STUDY DIRECTOR
  • Christie Newton, Dr.

    University of British Columbia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2010

First Posted

February 24, 2010

Study Start

June 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

June 29, 2016

Record last verified: 2016-06

Locations