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Table 1 Demographic characteristics by study and overall per protocol population

From: Identification of pain categories associated with change in pain in patients receiving placebo: data from two phase 3 randomized clinical trials in symptomatic knee osteoarthritis

Demographic characteristics placebo group, per protocol population
Parameter Target knee N = 771 Non-target knee N = 256
Sex - n (%)
 Male 280 (36.3) 82 (32.0)
 Female 491 (63.7) 174 (68.0)
Age (years)
 Mean (SD) 64.5 (6.5) 64.70 (6.3)
 Median (min, max) 64.1 (50, 81) 64.5 (50.4, 79.5)
Age group (years) – n (%)
  < 65 456 (59.1) 137 (53.5)
  ≥ 65 315 (40.9) 119 (46.5)
Race – n (%)
 Caucasian 666 (86.4) 228 (89.1)
 Asian 103 (13.4) 27 (10.5)
 Other 2 (0.3) 1 (0.4)
BMI (kg/m2)
 Mean (SD) 28.6 (4.7) 28.6 (4.4)
 Median (min, max) 27.9 (17.3, 45.9) 28.1 (19.6, 43.3)
KL Score - n (%)
 KL 0 N/A 5 (2)
 KL 1 N/A 37 (14.5)
 KL 2 641 (83.1) 130 (50.8)
 KL 3 130 (16.9) 73 (28.5)
 KL4 N/A 10 (3.9)
JSW (mm)
 Mean (SD) 3.43 (0.99) 3.15 (1.56)
 Median (min, max) 3.4 (1.8, 6.7) 3.39 (0.0, 7.3)
WOMAC pain score (normalized 0–100) Mean (SD) Median (min, max) Mean (SD) Median (min, max)
 Total pain (Q1–5) 49 (15) 47 (10, 100) 50 (16) 47 (30, 96)
 Walking on flat surface (Q1) 47 (20) 47 (2, 100) 47 (21) 46 (2, 99)
 Stairs (up or down) (Q2) 65 (18) 65 (2, 100) 65 (19) 63 (13, 100)
 In bed at night (Q3) 42 (26) 41 (0, 100) 44 (24) 44 (0, 98)
 Sitting or lying (Q4) 42 (22) 40 (0, 100) 43 (22) 43 (0, 100)
 Standing(Q5) 49 (21) 49 (0, 100) 49 (20) 48 (3, 100)
 Weight-bearing Composite (Q1, 2, 5) 53 (15) 52 (2, 100) 53 (17) 51 (18, 96)
 Non-weight-bearing Composite (Q3, Q4) 42 (21) 40 (0, 100) 44 (21) 41 (0–96)
  1. Trial 1: NCT00486434. Trial 2: NCT00704847. Non-target knees is a sub-group matching the pain inclusion criteria of the target knee within the per-protocol population. Both trials 1 and 2 were phase three randomized trials with a duration of 2 years, evaluating the effect of oral salmon calcitonin in symptomatic knee osteoarthritis on radiographic progression and symptoms. BMI Body Mass Index, KL-score Kellgren-Lawrence, JSW Joint Space Width, WOMAC Western Ontario and McMaster Universities Arthritis Index