SrRan 1 g/day (n=113) | SrRan 2 g/day (n=105) | Placebo (n=112) | p Value* | Placebo versus SrRan 1 g/day p Value** | Placebo versus SrRan 2 g/day p Value** | SrRan 1 g/day versus SrRan 2 g/day p Value** | |
---|---|---|---|---|---|---|---|
Demographics and clinical | |||||||
Age, years | 60±7 | 63±7 | 62±8 | 0.062 | 0.307 | >0.999 | 0.059 |
Women, n (%) | 70 (62%) | 70 (67%) | 76 (68%) | 0.616† | |||
BMI, kg/m² | 30±5 | 30±5 | 30±5 | 0.684 | |||
WOMAC | |||||||
Pain (0–100) | 42.0±20.4 | 44.5±20.0 | 38.5±21.4 | 0.068 | 0.438 | 0.079 | 0.927 |
Function (0–100) | 42.5±20.8 | 42.3±23.1 | 39.3±22.4 | 0.476 | |||
Stiffness (0–100) | 47.1±23.4 | 48.9±24.8 | 43.0±23.4 | 0.182 | |||
Total (0–300) | 132.9±59.0 | 135.1±62.1 | 122.1±62.9 | 0.284 | |||
Pain VAS (0–100 mm) | 51.1±21.5 | 54.9±23.2 | 49.8 ±23.9 | 0.211 | |||
Imaging | |||||||
Kellgren–Lawrence, n (%) | |||||||
Grade 1 | – | – | – | ||||
Grade 2 | 77 (68%) | 68 (65%) | 75 (67%) | 0.866† | |||
Grade 3 | 36 (32%) | 37 (35%) | 37 (33%) | ||||
Joint space width (mm) | 3.49±0.85 | 3.54 ±0.82 | 3.50 ±0.74 | 0.820 | |||
MRI (mm³) | |||||||
Meniscal extrusion (yes) | 19 (17%) | 15 (14%) | 26 (23%) | 0.210† | |||
Presence of BML (yes) | 44 (39%) | 35 (33%) | 46 (41%) | 0.482† | |||
Global knee | 11 439±3012 | 11 708±3313 | 11 076±2827 | 0.400 | |||
Femur | 7883 ±2141 | 8138 ±2276 | 7686 ±2003 | 0.374 | |||
Plateau | 3556 ±966 | 3570 ±1145 | 3390 ±895 | 0.430 | |||
Medial compartment | |||||||
Femur | 3833 ±1009 | 3965 ±1075 | 3730 ±955 | 0.286 | |||
Plateau | 1611 ±448 | 1624 ±523 | 1540 ±432 | 0.509 | |||
Lateral compartment | |||||||
Femur | 4050 ±1213 | 4173 ±1274 | 3956 ±1118 | 0.555 | |||
Plateau | 1945 ±580 | 1946 ±675 | 1849 ±534 | 0.524 |
The results are shown as mean±SD unless otherwise indicated.
p Values were assessed using the *Kruskal–Wallis test, the †χ2 test and the **Mann–Whitney test with Bonferroni adjustment.
BMI, body mass index; BML, bone marrow lesion; mITT, modified intention-to-treat; n, number of participants; SrRan, strontium ranelate; VAS, Visual Analogue Scale (0 mm=no pain, 100 mm=most severe pain); WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index (each subscale, 100=worst score; total scale, 300=worst score).