Abstract | OBJECTIVE: METHODS: Double-blind, randomized, placebo-controlled five-year study. Primary assessment criterion was change in radiographic joint space width between baseline and follow-up at 5 years. Secondary outcome criteria included Lequesne algofunctional index (LAI), pain on passive motion and consumption of non-steroidal antiinflammatory drugs ( NSAIDs). The patients received 10 courses of injections of placebo or GP-C 2 ml intramuscularly in 5 years (two courses each year). Each course included 15 injections administered twice weekly. RESULTS: There were 277 patients with knee OA and 117 patients with hip OA. Control and GP-C treated groups were comparable as to sex, age, duration of disease, body weight, X-ray stage and value of LAI at the baseline. Knee joint space at 5 years decreased 0.37+/-0.08 (mean+/-standard deviation) mm for GP-C and 0.42+/-0.08 mm for placebo groups (P=0.68). Hip joint space at 5 years decreased 0.21+/-0.08 mm for GP-C and 0.22+/-0.08 mm for placebo groups (P=0.53). In a subset of patients with hip OA, Kellgren-Lawrence> or =2 and JSW> or =1 mm, there was a trend in favor of GPC for lower joint space narrowing in 5 years (P=0.11). In addition, there were no statistical differences between the treatment groups in LAI, pain on passive motion and consumption of NSAIDs. Side-effects after GP-C (14.5%) were rare, mild and not more frequent than in the placebo group (15%). CONCLUSION: We were not able to demonstrate a structure modifying effect of GP-C in OA of the hip or knee. Radiographic progression of OA in both knee and hip OA was lower than expected in both study groups.
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Authors | K Pavelká, J Gatterová, V Gollerova, Z Urbanová, M Sedlácková, R D Altman |
Journal | Osteoarthritis and cartilage
(Osteoarthritis Cartilage)
Vol. 8
Issue 5
Pg. 335-42
(Sep 2000)
ISSN: 1063-4584 [Print] England |
PMID | 10966839
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright 2000 OsteoArthritis Research Society International. |
Chemical References |
- Antirheumatic Agents
- Glycosaminoglycans
- A73025
|
Topics |
- Adult
- Aged
- Antirheumatic Agents
(adverse effects, therapeutic use)
- Disease Progression
- Double-Blind Method
- Female
- Follow-Up Studies
- Glycosaminoglycans
(adverse effects, therapeutic use)
- Humans
- Male
- Middle Aged
- Osteoarthritis, Hip
(drug therapy, pathology)
- Osteoarthritis, Knee
(drug therapy, pathology)
- Prospective Studies
- Treatment Outcome
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