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OP0052 Glucosamine sulfate as an osteoarthritis disease modification agent: a confirmatory, long-term, randomised, placebo-controlled, indipendent study
  1. K Pavelka1,
  2. J Gatterova1,
  3. M Olejarova1,
  4. S Machacek1,
  5. C Gonzalez2,
  6. G Giacovelli2,
  7. LC Rovati2
  1. 1Institute of Rheumatology, Prague, Czech Republic
  2. 2Rotta Research Lab. S.p. A., Monza, Italy

Abstract

Background Recent data showed that glucosamine sulfate is an osteoarthritis disease modifying agent.1 International guide-lines on clinical development of osteoarthritis drugs recommend to perform at least two independent studies to confirm the drug properties.

Objectives To confirm the effects of glucosamine sulfate as a disease modifying agent.

Methods Randomised, double-blind, placebo-controlled, study. 202 patients with knee-osteoarthritis (ACR criteria) were randomised to glucosamine sulfate 1500 mg once-a-day p.o., or placebo for 3 years. The minimum joint space width (JSW) of the narrowest medial compartment of the tibio-femoral joint at 3 years was the study structure primary endpoint, and a secondary endpoint at 1 and 2 years. JSW was measured visually by a 0.1 mm graduated magnifying glass, on standardised weight-bearing antero-posterior radiographs of each knee, in full extension. Symptoms were assessed by both the WOMAC LK 3.0 version and the Lequesne indices.

Results The two study groups were comparable for demographic and disease characteristics and represented the standard primary-knee-osteoarthritis population. The placebo group presented a progressive joint space narrowing (JSN) at each year of evaluation, while glucosamine sulfate presented no average JSN at any point of evaluation. Results at 3 years are shown in the Table 1 below. Glucosamine sulfate significantly improved symptoms as measured by both the Lequesne: (20–25% vs. <10% with placebo) and the WOMAC (15–20% vs. <2%) indices. No significant differences were seen in the reported adverse events rate, while more patients on the placebo group prematurely left the study, without reaching a statistical significance.

Placebo
(N = 101)
Glucosamine Sulfate
(N = 101)
JSW enrolment (mm) 3.59 (0.16)3.97 (0.14)
JSN 3 years (mm) -0.19 (0.05)+0.02 (0.05)**
Lequesne enrolment (points) 8.9 (0.2)9.0 (0.2)
Δ 3 years (points) -0.8 (0.2)-1.7 (0.2)**
WOMAC enrolment points 30.5 (1.4)30.7 (1.4)
Δ 3 years (points) -4.9 (0.8)-8.0 (0.9)*
  • Data are mean (SE).

  • * p < 0.05.

  • ** p < 0.005 vs. placebo. Intention-to-treat (ITT) population.

  • Abstract OP0052 Table 1

    Conclusion This independent-confirmatory study demonstrated that glucosamine sulfate can be postulated as the first osteoarthritis structure modifying agent. Glucosamine sulfate also improved the disease symptoms in the long-term treatment of the disease, with a safety profile similar to placebo. The action of glucosamine sulfate on both the structure and the symptoms evolution of the disease postulate it as the first osteoarthritis modifying agent.

    Reference

    1. Lancet 2001;357:251–6

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