Demographical and clinical characteristics at baseline in randomised patients and in the ITT population
| Randomised patients (N=1683) | ITT population (N=1371) | |||||
|---|---|---|---|---|---|---|
| Strontium ranelate 1 g/day (n=558) | Strontium ranelate 2 g/day (n=566) | Placebo (n=559) | Strontium ranelate 1 g/day* (n=445) | Strontium ranelate 2 g/day* (n=454) | Placebo (n=472)* | |
| Demographical parameters | ||||||
| Age (years) | 62.4 (7.4) | 63.5 (7.5) | 62.8 (7.5) | 62.3 (7.0) | 63.1 (7.3) | 62.8 (7.3) |
| Sex (female) | 394 (71%) | 399 (71%) | 392 (70%) | 309 (69%) | 311 (69%) | 326 (69%) |
| Body mass index (kg/m2) | 30.1 (5.1) | 29.8 (4.8) | 29.8 (5.1) | 30.1 (5.1) | 29.7 (4.8) | 29.6 (5.1) |
| Disease characteristics (target knee) | ||||||
| Joint space width (mm) | 3.45 (0.87) | 3.54 (0.80) | 3.51 (0.83) | 3.45 (0.86) | 3.53 (0.80) | 3.51 (0.82) |
| Duration of knee osteoarthritis (months) | 78.8 (78.1) | 76.6 (78.9) | 74.8 (76.3) | 80.0 (77.9) | 75.6 (76.6) | 76.6 (76.8) |
| Kellgren and Lawrence scale | ||||||
| Grade 1 | 2 (<1%) | 1 (<1%) | – | 2 (<1%) | 1 (<1%) | – |
| Grade 2 | 341 (61%) | 347 (61%) | 350 (63%) | 268 (60%) | 274 (60%) | 299 (63%) |
| Grade 3 | 214 (38%) | 218 (39%) | 209 (37%) | 174 (40%) | 179 (40%) | 173 (37%) |
| Physical assessment | ||||||
| Swelling | 92 (17%) | 91 (16%) | 104 (19%) | 69 (16%) | 70 (16%) | 88 (19%) |
| Warmth | 26 (5%) | 17 (3%) | 22 (4%) | 20 (5%) | 12 (3%) | 14 (3%) |
| Effusion | 70 (13%) | 60 (11%) | 72 (13%) | 52 (12%) | 46 (10%) | 66 (14%) |
| Pain (VAS) (mm/100 mm) | 52.6 (22.5) | 55.6 (21.9) | 53.7 (22.4) | 51.6 (22.4) | 55.7 (22.1) | 53.7 (22.5) |
| WOMAC scale† | ||||||
| Total score | 132.0 (62.0) | 136.4 (62.5) | 129.0 (62.5) | 130.2 (60.9) | 136.1 (62.6) | 128.3 (62.0) |
| Pain subscore | 42.7 (21.3) | 44.5 (21.8) | 42.2 (21.6) | 42.1 (21.0) | 44.7 (22.1) | 41.8 (21.5) |
| Stiffness subscore | 46.8 (24.9) | 48.3 (25.0) | 45.5 (25.2) | 46.0 (24.7) | 48.3 (24.6) | 45.2 (25.0) |
| Physical function subscore | 42.5 (21.9) | 43.7 (22.5) | 41.0 (22.4) | 41.8 (21.4) | 43.5 (22.7) | 40.9 (22.3) |
Data are number of patients (%) or means (SD).
*No significant difference for any variable between the corresponding groups for randomised or ITT patients.
†WOMAC score is measured on a 300-mm scale; WOMAC subscores are normalised to 100 mm.
ITT, intention-to-treat; VAS, visual analogue scale; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.