A 12-week randomized, double-blind, placebo-controlled multicenter study of choline-stabilized orthosilicic acid in patients with symptomatic knee osteoarthritis

BMC Musculoskeletal Disorders

Research Article

Piet Geusens¹  Dirk Vanden Berghe²  Karel Pavelka³  Jozef Rovensky⁴  Mario Calomme⁵  Nathalie Demeester⁵  Johan Vanhoof⁶ 

[1] Biomedical Research Institute (BIOMED), Hasselt University, Diepenbeek, Belgium;Rheumatology, Maastricht UMC, Maastricht, The Netherlands;ReumaClinic, Bretheistraat 149, 3600, Genk, Belgium;Department of Pharmaceutical Sciences, University of Antwerp, Antwerp-Wilrijk, Belgium;Institute of Rheumatology, Prague, Czech Republic;Nábrežie I. Krasku 4782/4, Piešťany, Slovakia;Research & Development, Bio Minerals NV, Destelbergen, Belgium;ReumaClinic, Bretheistraat 149, 3600, Genk, Belgium;

关键词: Osteoarthritis;    Knee;    Choline-stabilized orthosilicic acid;    WOMAC;    Cartilage degradation marker;    Silicon;    Choline;   

DOI  :  10.1186/s12891-016-1370-7

 received in 2016-05-27, accepted in 2016-12-19,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundThe aim of this study was to assess the efficacy of choline-stabilized orthosilicic acid (ch-OSA) in patients with symptomatic knee osteoarthritis (OA).MethodsIn a multicenter, double-blind, placebo-controlled study, 211 patients with knee OA (Kellgren and Lawrence grade II or III) and moderate to moderately severe pain were randomly allocated to ch-OSA or placebo for 12 weeks. The primary outcome was the change in the WOMAC pain subscale from baseline to week 12. Secondary outcomes were changes from baseline to week 12 in WOMAC total, WOMAC stiffness, WOMAC physical function, Subject Global Assessment and levels of cartilage degradation biomarkers C-terminal telopeptide of collagen type II (CTX-II) and cartilage oligomeric matrix protein (COMP). Pre-specified subgroup analyses included the effect of gender.ResultsA total of 166 (120 women, 46 men) patients were included in the analysis (87 and 79 in the ch-OSA and placebo group, respectively). In the total study population, no differences were observed between the two treatment groups for the different outcomes but significant treatment x gender interactions were found. In men taking ch-OSA, a significant improvement in WOMAC total, WOMAC stiffness and WOMAC physical function as well as a lower increase in biomarker levels of cartilage degradation was observed, but not in women. The change in WOMAC pain showed a similar positive trend in men taking ch-OSA.ConclusionAfter 12 weeks of treatment, no effect was found of ch-OSA in the total study population on clinical parameters and biomarkers, but a gender interaction was observed. In men, ch-OSA was found effective in reducing symptoms of knee OA, which was associated with a slight but significant reduction of biomarkers that are related to cartilage degradation.Trial registrationThe study was registered retrospectively: ISRCTN88583133. Registration date: 2015-10-07.

【 授权许可】

CC BY   
© The Author(s). 2017