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

Geusens, Piet; Pavelka, Karel; Rovensky, Jozef; Vanhoof, Johan; Demeester, Nathalie; Calomme, Mario; Vanden Berghe, Dirk

doi:10.1186/s12891-016-1370-7

Table 3 Gender-specific subgroups: Overview of the absolute clinical outcome scores and biomarker values at baseline, week 2, week 6 and week 12 in the placebo and choline-stabilized orthosilicic acid (ch-OSA) group

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

	Placebo (n = 79)								ch-OSA (n = 87)
	Male (n = 24)				Female (n = 55)				Male (n = 22)				Female (n = 65)
	Baseline (mean ± SD)	Week 2 (mean ± SD)	Week 6 (mean ± SD)	Week 12 (mean ± SD)	Baseline (mean ± SD)	Week 2 (mean ± SD)	Week 6 (mean ± SD)	Week 12 (mean ± SD)	Baseline (mean ± SD)	Week 2 (mean ± SD)	Week 6 (mean ± SD)	Week 12 (mean ± SD)	Baseline (mean ± SD)	Week 2 (mean ± SD)	Week 6 (mean ± SD)	Week 12 (mean ± SD)
WOMAC total score (/100 mm)	42.0 ± 22.4	37.5^a ± 26.2	34.1^a ± 24.3	34.7 ± 30.7	43.6 ± 19.6	39.8 ± 19.0	32.1^{a, b} ± 19.9	31.2 ^a ± 20.5	42.5 ± 20.9	36.1^a ± 22.1	26.8^a ± 22.8	24.2^a ± 21.3	40.4 ± 19.0	37.7 ± 20.7	30.4^{a, b} ± 21.2	31.1^a ± 23.4
WOMAC pain score (/100 mm)	42.5 ± 22.7	35.1^a ± 24.5	32.6^a ± 24.0	33.0 ± 31.2	40.6 ± 19.4	37.2 ± 19.7	29.3^{a, b} ± 19.8	28.2 ^a ± 20.1	41.3 ± 19.3	32.2^a ± 20.0	24.3^a ± 21.5	21.6^a ± 19.6	37.1 ± 20.0	35.5 ± 21.9	28.8^{a, b} ± 22.0	27.6^a ± 22.9
WOMAC stiffness score (/100 mm)	43.8 ± 25.3	40.0 ± 27.3	33.5 ± 26.4	38.2 ± 29.6	45.9 ± 24.5	39.5^a ± 23.2	32.4^{a, b} ± 22.2	32.2 ^a ± 22.8	46.2 ± 21.8	37.2^a ± 25.3	28.8^a ± 23.8	24.1^a ± 23.4	43.3 ± 24.1	39.4 ± 22.5	31.1^{a, b} ± 22.6	32.0^a ± 25.3
WOMAC function score (/100 mm)	41.7 ± 23.3	37.9 ± 27.3	34.6 ± 25.2	34.9 ± 31.0	45.9 ± 24.5	39.5 ± 23.2	32.4^{a, b} ± 22.2	32.2 ^a ± 22.8	42.4 ± 22.2	27.1 ± 22.9	27.3^a ± 23.5	25.0^a ± 22.3	43.3 ± 24.1	39.4 ± 22.5	31.1^{a, b} ± 22.6	32.0^a ± 25.3
Subject Global Assessment (/100 mm)	51.1 ± 26.0	41.7 ± 22.4	33.3 ^a ± 23.4	33.8^a ± 24.3	48.6 ± 19.9	37.9^a ± 18.8	33.5^{a, b} ± 19.7	32.0 ^a ± 22.2	51.5 ± 18.3	36.6^a ± 20.9	24.6^{a, b} ± 20.8	25.8 ^a ± 23.7	49.6 ± 18.3	42.7^a ± 22.8	36.5^{a, b} ± 24.9	34.2^a ± 24.6
CTX-II/Creatinine (ng/mmol)	389.8 ± 178.0	-	-	565.2^a ± 267.8	425.6 ± 196.5	-	-	508.1^a ± 259.5	364.0 ± 144.7	-	-	437.4^a ± 171.8	454.3 ± 229.0	-	-	568.3^a ± 282.6
COMP (U/L)	11.1 ± 3.0	-	-	13.0^a ± 3.6	10.6 ± 2.7	-	-	10.6 ± 3.2	10.9 ± 2.7	-	-	10.6 ± 2.7	10.6 ± 2.9	-	-	11.3^a ± 2.8
Silicon (μg/L)	54.4 ± 28.1	-	-	59.2 ± 36.0	49.5 ± 35.6			67.8 ^a ± 44.4	68.4 ± 38.0	-	-	99.3^{a, c} ± 42.7	57.0 ± 35.3	-	-	121.3^{a, c} ± 59.1

^asignificant difference from baseline within the group; ^b significant difference from week 2 within the group; ^c significant difference between groups (placebo versus ch-OSA); -: not applicable; Number of patients without outliers for CTX-II: placebo males (n = 23), placebo females (n = 43), ch-OSA males (n = 18), ch-OSA females (n = 50); Number of patients without outliers for COMP: placebo males (n = 22), placebo females (n = 52), ch-OSA males (n = 21), ch-OSA females (n = 59); Number of patients without outliers for Silicon: placebo males (n = 19), placebo females (n = 50), ch-OSA males (n = 19), ch-OSA females (n = 56)

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