Table 1

mITT baseline demographics, clinical and imaging characteristics

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, years60±763±762±80.0620.307>0.9990.059
 Women, n (%)70 (62%)70 (67%)76 (68%)0.616†
 BMI, kg/m²30±530±530±50.684
 WOMAC
  Pain (0–100)42.0±20.444.5±20.038.5±21.40.0680.4380.0790.927
  Function (0–100)42.5±20.842.3±23.139.3±22.40.476
  Stiffness (0–100)47.1±23.448.9±24.843.0±23.40.182
  Total (0–300)132.9±59.0135.1±62.1122.1±62.90.284
 Pain VAS (0–100 mm)51.1±21.554.9±23.249.8 ±23.90.211
Imaging
 Kellgren–Lawrence, n (%)
  Grade 1
  Grade 277 (68%)68 (65%)75 (67%)0.866†
  Grade 336 (32%)37 (35%)37 (33%)
 Joint space width (mm)3.49±0.853.54 ±0.823.50 ±0.740.820
 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 knee11 439±301211 708±331311 076±28270.400
 Femur7883 ±21418138 ±22767686 ±20030.374
 Plateau3556 ±9663570 ±11453390 ±8950.430
Medial compartment
 Femur3833 ±10093965 ±10753730 ±9550.286
 Plateau1611 ±4481624 ±5231540 ±4320.509
Lateral compartment
 Femur4050 ±12134173 ±12743956 ±11180.555
 Plateau1945 ±5801946 ±6751849 ±5340.524
  • 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).