| Time |  | ||
---|---|---|---|---|
Evaluation methods/Groups | Baseline | Week 4 | Week 8 | P-values |
Function - kinetic gait analysis (%BW) | Â | Â | Â | Â |
Placebo-control | 71.4 (3.7) | 27 (11.0) | 32.2 (12.4) | *<0.01 |
Tiludronate | 73.6 (6.1) | 35.1 (15.5) | 43.6 (9.0) | § = 0.05 ¶ <0.01 |
Pain - Visual analog scale (VAS, measurement) | Â | Â | Â | Â |
Placebo-control | 0.0 (0.0) | 37.6 (14.3) | 26.8 (11.1) | *<0.01 |
Tiludronate | 0.0 (0.0) | 26.9 (18.9) | 15.6 (9.2) | Â |
Pain - Numerical rating scale (NRS, score) | Â | Â | Â | Â |
Placebo-control | 0.0 (0.0) | 19.4 (4.3) | 18.3 (3.7) | Â |
Tiludronate | 0.0 (0.0) | 15.5 (5.4) | 15.0 (3.4) | § = 0.03 |
Pain - Electrodermal activity (EDA, reading) | Â | Â | Â | Â |
Placebo-control | 4.5 (2.5) | 6.4 (2.5) | 5.3 (2.4) | Â |
Tiludronate | 4.2 (2.7) | 3.6 (2.5) | 3.9 (2.4) | Â |
Function - Telemetered actimetry recording (count) | Â | Â | Â | Â |
Daily averaged total intensity (DATI, no unit) | Â | Â | Â | Â |
Placebo-control | 97.9 (41.4) | 79.1 (22.7) | 85.7 (35.8) | Â |
Tiludronate | 82.3 (25.4) | 104.5 (44.6) | 91.2 (33.1) | ¶ = 0.04 |
Daily averaged active intensity (DAAI, no unit) | Â | Â | Â | Â |
Placebo-control | 390.9 (101.3) | 360.6 (73.9) | 379.1 (127.1) | Â |
Tiludronate | 390.2 (82.9) | 502.6 (145.7) | 443.1 (117.1) | ¶ = 0.04 |