Table 3.
Bone marrow lesion changes between interim visits
| 100 μg cohort (n = 56) Mean (95 % CI) | Matched placebo (n = 18) Mean (95 % CI) | p - value | ||
|---|---|---|---|---|
| Whole knee | Baseline | 3.3 (2.5, 4.1) | 3.3 (1.4, 5.2) | 0.642 |
| Delta sum | ||||
| 0 to 3 months | −0.02 (−0.38, 0.34) | −0.17 (−0.85, 0.52) | 0.682 | |
| 3 to 6 months | −0.04 (−0.41, 0.34) | −0.06 (−0.37, 0.26) | 0.933 | |
| 6 to 12 months | −0.14 (−0.54, 0.26) | 0.44 (−0.15, 1.04) | 0.054 | |
| Delta subregion | ||||
| 0 to 3 months | 0.02 (−0.28, 0.32) | −0.22 (−0.87, 0.43) | 0.597 | |
| 3 to 6 months | −0.05 (−0.37, 0.27) | −0.06 (−0.37, 0.26) | 0.911 | |
| 6 to 12 months | −0.14 (−0.48, 0.19) | 0.44 (−0.15, 1.04) | 0.042* | |
| LTFJ | Baseline | 0.7 (0.3, 1.1) | 0.7 (0.0, 1.4) | 0.981 |
| Delta sum | ||||
| 0 to 3 months | 0.04 (−0.12, 0.19) | 0.00 (−0.17, 0.17) | 0.859 | |
| 3 to 6 months | 0.13 (−0.11, 0.36) | −0.11 (−0.40, 0.18) | 0.155 | |
| 6 to 12 months | −0.13 (−0.39, 0.14) | 0.22 (−0.10, 0.54) | 0.062 | |
| Delta subregion | ||||
| 0 to 3 months | 0.04 (−0.12, 0.19) | 0.00 (−0.17, 0.17) | 0.859 | |
| 3 to 6 months | 0.09 (−0.12, 0.30) | −0.11 (−0.40, 0.18) | 0.155 | |
| 6 to 12 months | −0.05 (−0.27, 0.16) | 0.22 (−0.10, 0.54) | 0.064 | |
| MTFJ | Baseline | 1.6 (1.1, 2.2) | 1.1 (0.3, 1.9) | 0.418 |
| Delta sum | ||||
| 0 to 3 months | −0.11 (−0.41, 0.20) | −0.11 (−0.49, 0.27) | 0.727 | |
| 3 to 6 months | −0.07 (−0.27, 0.13) | 0.06 (−0.21, 0.32) | 0.530 | |
| 6 to 12 months | 0.07 (−0.21, 0.35) | 0.17 (−0.38, 0.71) | 0.673 | |
| Delta subregion | ||||
| 0 to 3 months | −0.07 (−0.30, 0.16) | −0.17 (−0.47, 0.14) | 0.574 | |
| 3 to 6 months | −0.05 (−0.21, 0.10) | 0.06 (−0.21, 0.32) | 0.525 | |
| 6 to 12 months | 0.02 (−0.20, 0.24) | 0.17 (−0.38, 0.71) | 0.646 | |
| PFJ | Baseline | 1.0 (0.5, 1.5) | 1.5 (0.1, 2.9) | 1.000 |
| Delta sum | ||||
| 0 to 3 months | 0.05 (−0.09, 0.20) | −0.06 (−0.45, 0.34) | 0.772 | |
| 3 to 6 months | −0.09 (−0.24, 0.06) | 0.00 (−0.24, 0.24) | 0.647 | |
| 6 to 12 months | −0.09 (−0.31, 0.13) | 0.06 (−0.38, 0.49) | 0.123 | |
| Delta subregion | ||||
| 0 to 3 months | 0.05 (−0.09, 0.20) | −0.06 (−0.45, 0.34) | 0.772 | |
| 3 to 6 months | −0.09 (−0.24, 0.06) | 0.00 (−0.24, 0.24) | 0.647 | |
| 6 to 12 months | −0.11 (−0.32, 0.10) | 0.06 (−0.38, 0.49) | 0.115 |
CI confidence interval, LTFJ lateral tibio-femoral joint (includes 5 subregions), MTFJ medial tibio-femoral joint (includes 5 subregions), PFJ patello-femoral joint (includes 4 subregions). Possible score range for bone marrow lesion is 0–3 for each subregion at baseline, 3-, 6- and 12-month
*Statistically significant at p ≤ 0.05