Table 1.
Demographic characteristics by study and overall per protocol population
| 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) |
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