Outcomes in the intention-to-treat population (n=1371)
| Strontium ranelate 1 g/day (n=445) | Strontium ranelate 2 g/day (n=454) | Placebo (n=472) | |||||
|---|---|---|---|---|---|---|---|
| Value | Difference versus placebo E (SE), (95% CI) | p Value | Value | Difference versus placebo E (SE), (95% CI) | p Value | Value | |
| Primary endpoint, mean (SD) | |||||||
| Joint space width (mm) | −0.23 (0.56) | 0.14 (0.04) (0.05 to 0.23) | <0.001 | −0.27 (0.63) | 0.10 (0.04) (0.02 to 0.19) | 0.018 | −0.37 (0.59) |
| Progression of disease, n(%) | |||||||
| Radiological progression* | 99 (22%) | −10.80 (2.9) (−16.54 to −5.06) | <0.001 | 116 (26%) | −7.50 (3.0) (−13.34 to −1.66) | 0.012 | 156 (33%) |
| Radioclinical progression† | 32 (8%) | −3.94 (1.98) (−7.83 to −0.05) | 0.049 | 28 (7%) | −5.12 (1.91) (−8.86 to −1.37) | 0.008 | 53 (12%) |
| Symptoms of disease, mean (SD)‡ | |||||||
| WOMAC total score (/300 mm) | −41.8 (62.3) | −1.3 (4.0) (−9.0 to 6.5) | 0.749 | −51.9 (66.1) | −8.0 (4.0) (−15.7 to −0.2) | 0.045 | −40.7 (69.1) |
| WOMAC pain subscore (/100 mm) | −14.6 (22.6) | 0.1 (1.3) (−2.6 to 2.7) | 0.969 | −19.1 (23.7) | −3.0 (1.3) (−5.6 to −0.3) | 0.028 | −14.7 (23.5) |
| WOMAC stiffness subscore (/100 mm) | −15.6 (26.9) | −1.0 (1.6) (−4.1 to 2.1) | 0.523 | −18.3 (28.0) | −2.5 (1.6) (−5.6 to 0.6) | 0.120 | −14.0 (29.4) |
| WOMAC physical function subscore (/100 mm) | −12.2 (21.1) | −0.4 (1.3) (−3.0 to 2.2) | 0.772 | −15.0 (22.2) | −2.2 (1.3) (−4.7 to 0.4) | 0.099 | −11.7 (23.2) |
| Global knee pain (VAS), (/100 mm) | −22.9 (29.0) | −0.24 (1.64) (−3.45 to 2.97) | 0.884 | −28.5 (28.3) | −3.01 (1.60) (−6.20 to 0.19) | 0.065 | −24.2 (29.2) |
Values are number (%) at end for progressors, mean (SD) change from baseline to end for symptoms.
*Joint space narrowing (JSN) ≥0.5 mm over 3 years.
†JSN ≥0.5 mm and lack of improvement in WOMAC pain (≤20%) pain over 3 years.
‡WOMAC score is evaluated on a 300-mm scale; WOMAC subscores are normalised to 100 mm, and global knee pain is reported on a 100-mm scale.
VAS, visual analogue scale; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.