A 5-year randomized controlled, double-blind study of glycosaminoglycan polysulphuric acid complex (Rumalon®) as a structure modifying therapy in osteoarthritis of the hip and knee

K. Pavelká, J. Gatterová, V. Gollerova, Z. Urbanová, M. Sedlácková, Roy D Altman

Research output: Contribution to journalArticle

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Abstract

Objective: To determine the structure (disease) modifying effect of a glycosaminoglycan polypeptide association complex (GP-C; Rumalon®) in patients with knee and hip osteoarthritis (OA). 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 ≥2 and JSW≥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. (C) 2000 OsteoArthritis Research Society International.

Original languageEnglish (US)
Pages (from-to)335-342
Number of pages8
JournalOsteoarthritis and Cartilage
Volume8
Issue number5
DOIs
StatePublished - 2000

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Hip Osteoarthritis
Knee Osteoarthritis
Glycosaminoglycans
Double-Blind Method
Placebos
Acids
Polypeptides
Anti-Inflammatory Agents
X rays
Joints
Therapeutics
Pain
Injections
Hip Joint
Knee Joint
Osteoarthritis
Pharmaceutical Preparations
Body Weight
X-Rays
Rumalon

Keywords

  • Disease modification
  • Hip
  • Knee
  • Osteoarthritis
  • Rumalon®
  • X-ray progression

ASJC Scopus subject areas

  • Orthopedics and Sports Medicine

Cite this

A 5-year randomized controlled, double-blind study of glycosaminoglycan polysulphuric acid complex (Rumalon®) as a structure modifying therapy in osteoarthritis of the hip and knee. / Pavelká, K.; Gatterová, J.; Gollerova, V.; Urbanová, Z.; Sedlácková, M.; Altman, Roy D.

In: Osteoarthritis and Cartilage, Vol. 8, No. 5, 2000, p. 335-342.

Research output: Contribution to journalArticle

Pavelká, K. ; Gatterová, J. ; Gollerova, V. ; Urbanová, Z. ; Sedlácková, M. ; Altman, Roy D. / A 5-year randomized controlled, double-blind study of glycosaminoglycan polysulphuric acid complex (Rumalon®) as a structure modifying therapy in osteoarthritis of the hip and knee. In: Osteoarthritis and Cartilage. 2000 ; Vol. 8, No. 5. pp. 335-342.
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AU - Gatterová, J.

AU - Gollerova, V.

AU - Urbanová, Z.

AU - Sedlácková, M.

AU - Altman, Roy D

PY - 2000

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N2 - Objective: To determine the structure (disease) modifying effect of a glycosaminoglycan polypeptide association complex (GP-C; Rumalon®) in patients with knee and hip osteoarthritis (OA). 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 ≥2 and JSW≥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. (C) 2000 OsteoArthritis Research Society International.

AB - Objective: To determine the structure (disease) modifying effect of a glycosaminoglycan polypeptide association complex (GP-C; Rumalon®) in patients with knee and hip osteoarthritis (OA). 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 ≥2 and JSW≥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. (C) 2000 OsteoArthritis Research Society International.

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