Effect of Interventions on the Progression of Knee Osteoarthritis (KAPS)

Effect of Interventions on Progression of Knee Osteoarthritis - a Comparison of Effect of Glucosamine/Chondroitin or Diacerin Vs Placebo: Measured by Clinical, Radiological and Biochemical Parameters

There has been intensive search for a substance that can have disease-modifying activity for osteoarthritis. A number of medications have been reported to be of benefit on slowing progression of knee OA. This trial will be the first head to head comparison of these medications.

Patients aged between age 40 to 65 will be enrolled. Patients will be assessed clinically using two scoring systems, the WOMAC index for knee arthritis and the SF 36 for overall physical and mental health. The knee X rays will be assessed on Kellgren and Lawrence grading and will also be measured for joint space narrowing at follow up. The response to arthritis medications on slowing down cartilage loss will be measured biochemically with COMP levels.

Study Overview

• Status: Completed
• Conditions: Osteo Arthritis of the Knees
• Intervention / Treatment: Drug: Placebo; Drug: Glucosamine/Chondroitin; Drug: Diacerien

• Study Type: Interventional
• Enrollment (Actual): 322
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Sind
    • Karachi, Sind, Pakistan
      • The Indus Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients of either sex aged between 40 to 65 years with mild to moderate osteoarthritis of the knees.
• Patients should have history of knee pain for at least 6 months and on the majority of days during the preceding month
• Each joint will be scored separately so one patient with bilateral knee osteoarthritis will be counted as 2 knees.
• The osteoarthritis will be graded on basis of clinical score as well as seen on appropriately positioned x rays using the Kellgren and Lawrence grading. (Tibio femoral osteophytes of at least 1 mm, Kellgren Lawrence grading of 2 or 3)
• Patients with diabetes are sent to the diabetes clinic and are included once their HbA1c level becomes normal.
• Patients giving Informed consent

Exclusion Criteria:

• Patients with severe end stage tricompartmental osteoarthritis of the knees .
• Presence of uncontrolled systemic disease like chronic liver and renal disease
• Patients with diagnosis other than osteoarthritis, such as knee arthritis due to rheumatoid disease, gout, post traumatic arthritis
• Patients with history of surgery to any knee will have that knee excluded
• Pregnant or lactating mothers
• Patients with chronic anaemia
• Patients who get an injection in their affected knee

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Glucosamine/Chondroitin; Glucosamine/Chondroitin twice a day for a daily total dose of 1500 mg of Glucosamine and 1200 mg of Chondroitin. Tablets will have 750 mg Glucosamine Sulphate and 600 mg of Chondroitin Sulphate. These will be taken twice a day after breakfast and dinner.	Drug: Glucosamine/Chondroitin
Active Comparator: Diacerien; Diacerien 50 mg twice a day in capsule form. To be taken twice a day after breakfast and dinner	Drug: Diacerien; Other Names: Artrodar; Dirtacetylrhein
Placebo Comparator: Placebo pill; Placebo tablets with Zinc sulfate twice a day. These will contain pharamacologically non active ingredients (Usually expedients).	Drug: Placebo; Other Names: Zinc Sulphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in WOMAC score at 24 months in comparison to baseline score	Hypothesis:- At least one of the intervention drug will result in an improvement of at least 20 points on the WOMAC score at end of 2 years as compared to the placebo when compared to base line score	baseline, 24 months
Change to the SF-36 score at 24 months in comparison to baseline score	Hypothesis: At least one of the intervention drugs will result in an improvement of at least 20 points at end of two years when assessed using the SF36 total score as compared to the standard therapy placebo when compared with baseline score	24 months
Mean differences in blood serum COMP levels of study arms		24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in WOMAC score at 6 months in comparison to baseline score	6 months
Change in WOMAC score at 12 months in comparison to baseline score	12 months
Change in WOMAC score at 18 months in comparison to baseline score	18 months
Change to the SF-36 score at 6 months in comparison to baseline score	6 months
Change to the SF-36 score at 12 months in comparison to baseline score	12 months
Change to the SF-36 score at 18 months in comparison to baseline score	18 months

Collaborators and Investigators

• Sponsor: Indus Hospital and Health Network
• Investigators: Principal Investigator: Mansoor A Khan, MBBS, The Indus Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: June 27, 2014
• First Submitted That Met QC Criteria: June 27, 2014
• First Posted (Estimate): June 30, 2014

Study Record Updates

• Last Update Posted (Actual): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 28, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Dermatologic Agents; Astringents; Zinc Sulfate
• Other Study ID Numbers: TIH-Ortho-001