TABLE 3.
Subgroup analysis Bone mineral measurements at screening, 9 and 18 month DXA and their changes per ARM in CD and UC patients
| CD | UC | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| CALCITONIN | PLACEBO | CALCITONIN | PLACEBO | |||||||
| N | Mean (SD) | N | Mean (SD) | P | N | Mean (SD) | N | Mean (SD) | p | |
| TOTAL BODY | ||||||||||
| Screening to 18 mos | ||||||||||
| ZTBBMDscreening | 26 | −1.37 (0.92) | 20 | −1.43 (0.68) | 0.83 | 4 | −0.58 (0.67) | 12 | −0.93 (0.77 | 0.54 |
| ZTBBMD18 | 19 | −1.58 (0.93) | 18 | −1.51 (0.73) | 0.79 | 4 | −0.83 (0.33) | 8 | −0.81(0.87) | 0.44 |
| ΔZTBBMD(18-0) | 18 | −0.19 (0.64) | 18 | −0.05 (0.53) | 0.75 | 4 | −0.25 (0.35) | 8 | 0.13 (0.47) | 0.19 |
| Screening to 9 mos | ||||||||||
| ZTBBMD9 | 20 | −1.47 (0.9) | 15 | −1.43 (0.88) | 0.92 | 3 | −0.93 (0.51) | 8 | −0.88 (0.94) | 0.92 |
| ΔZTBBMD(9-0) | 19 | −0.08 (0.53) | 15 | 0.01 (0.52) | 0.93 | 3 | −0.17 (0.42) | 8 | 0.04 (0.5) | 0.55 |
| Screening to 18 mos (bone age adjusted) | ||||||||||
| ZTBBMD (BA)screening | 14 | −1.06 (1.04) | 17 | −0.95 (0.86) | 0.72 | 4 | −0.28 (0.33) | 10 | −0.91 (0.69) | 0.11 |
| ZTBBMD (BA)18 | 17 | −0.96 (1.02) | 14 | −1.12 (0.81) | 0.63 | 4 | −0.63 (0.57) | 6 | −0.88 (0.97) | 0.65 |
| ΔZTBBMD(BA)(18-0) | 17 | −0.08 (0.70) | 15 | −0.25 (0.53) | 0.47 | 4 | −0.35 (0.68) | 6 | −0.12 (0.87) | 0.66 |
| SPINE | ||||||||||
| Screening to 18 mos | ||||||||||
| ZSBMDscreening | 27 | −1.64 (0.68) | 20 | −1.61 (0.82) | 0.87 | 4 | −0.9 (0.37) | 12 | −1.4 (0.61) | 0.13 |
| ZSBMD18 | 22 | −1.43 (0.67) | 19 | −1.47 (0.9) | 0.91 | 4 | −0.85 (0.26) | 10 | −1.08 (0.79) | 0.59 |
| ΔZSBMD(18-0) | 22 | 0.21 (0.56) | 19 | 0.14 (0.51) | 0.67 | 4 | 0.05 (0.37) | 10 | 0.25 (0.51) | 0.5 |
| Screening to 9 mos | ||||||||||
| ZSBMD9 | 20 | −1.49 (0.58) | 15 | −1.73 (0.82) | 0.31 | 3 | −1.1 (0.26) | 8 | −1.13 (0.64) | 0.95 |
| ΔZSBMD(9-0) | 20 | 0.21 (0.37) | 15 | −0.15 (0.5) | 0.02 | 3 | −0.07 (0.47) | 8 | 0.28 (0.32) | 0.2 |
| Screening to 18 mos (bone age adjusted) | ||||||||||
| ZSBMD (BA)screening | 14 | −1.06 (1.04) | 17 | −0.95 (0.86) | 0.72 | 4 | −0.58 (0.24) | 10 | −1.27 (0.62) | 0.06 |
| ZSBMD(BA)18 | 17 | −0.98 (0.69) | 13 | −1.27 (0.97) | 0.34 | 4 | −0.68 (0.35) | 6 | −0.97 (0.61) | 0.42 |
| ΔZSBMD(BA)(18-0) | 17 | 0.41 (0.62) | 15 | −0.03 (0.72) | 0.07 | 4 | −0.1 (0.54) | 6 | 0.18 (0.75) | 0.54 |
CD: Crohn disease, UC: ulcerative colitis, SD: standard deviation, ZTBBMD: Total body BMD Z-score, ΔZTBBMD: change in total body BMD Z-score (from screening to 9 or 18 mos), ZSBMD: Spine BMD Z-score, ΔZSBMD: change in spine BMD Z-score (from screening to 9 or 18 mos), (BA): adjusted for bone age