Clinical trial NCT02178137: Effect of Interventions on the Progression of Knee Osteoarthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteo Arthritis of the Knees
Lead sponsor: Indus Hospital and Health Network
Sponsor class: OTHER
First posted: 2014-06-30
Enrollment: 322
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in WOMAC score at 24 months in comparison to baseline score
timeFrame: baseline, 24 months
measure: Change to the SF-36 score at 24 months in comparison to baseline score
timeFrame: 24 months
measure: Mean differences in blood serum COMP levels of study arms
timeFrame: 24 months
Secondary outcomes:
measure: Change in WOMAC score at 6 months in comparison to baseline score
timeFrame: 6 months
measure: Change in WOMAC score at 12 months in comparison to baseline score
timeFrame: 12 months
measure: Change in WOMAC score at 18 months in comparison to baseline score
timeFrame: 18 months
measure: Change to the SF-36 score at 6 months in comparison to baseline score
timeFrame: 6 months
measure: Change to the SF-36 score at 12 months in comparison to baseline score
timeFrame: 12 months
measure: Change to the SF-36 score at 18 months in comparison to baseline score
timeFrame: 18 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: The Indus Hospital
state: Sind
Study officials:
affiliation: The Indus Hospital
name: Mansoor A Khan, MBBS
role: PRINCIPAL_INVESTIGATOR
References: