TABLE 1.
Characteristics per arm at enrollment or screening DXA
| CALCITONIN | PLACEBO | p | ||||
|---|---|---|---|---|---|---|
| DEMOGRAPHICS 1 | N | N(%) or Mean (SD) | N | N(%) or Mean (SD) | ||
| Gender | Male/Female | 17 /14 (54.8%/45.2%) | 18/14 (56.2%/43.8%) | 0.91 | ||
| Race | Caucasian/Others | 29/2 (93.5%/6.5%) | 27/5 (84.4%/15.6%) | 0.25 | ||
| Pubertal stage | pre/pubertal/post | 8/18/5 (25.8%/58.1%/16.1%) | 9/17/6 (28.1%/53.1%/18.1%) | 0.92 | ||
| Age (yrs) | 31 | 14.4 (3) | 32 | 14.8 (3.4) | 0.62 | |
| Bone age (yrs) | 30 | 13.6 (3.3) | 30 | 13.6 (3.1) | 0.93 | |
| ANTHROPOMETRICS/BODY COMPOSITION 1 | ||||||
| Height Z-score | 31 | −0.76 (0.91) | 32 | −0.89 (1.17) | 0.61 | |
| Weight Z-score | 31 | −0.31 (1.09) | 32 | −0.51 (1.15) | 0.48 | |
| BMI Z-score | 31 | 0.06 (0.95) | 32 | −0.04 (1.08) | 0.70 | |
| Zlean (Ht) | 30 | −0.12 (1.03) | 32 | −0.13 (1.31) | 0.98 | |
| Z%fat (age) | 30 | −0.8 (1.43) | 32 | −0.53 (1.11) | 0.39 | |
| DISEASE PARAMETERS 1 | ||||||
| Diagnosis | CD/UC (%) | 27/4 (87.1%/12.9%) | 20/12 (62.5%/37.5%) | 0.02 | ||
| Disease duration (months) | 31 | 41 (40) | 31 | 33 (34) | 0.61 | |
| Lifetime glucocorticoids to screening DXA (mg) | 26 | 3819.7 (3326.1) | 28 | 4475.9 (4362.8) | 0.77 | |
| Lifetime surgery (IBD-related) | 31 | 2 (6.5%) | 32 | 5 (15.6%) | 0.25 | |
| Lifetime hospitalization (IBD-related) | 31 | 13 (41.9%) | 32 | 18 (58.1%) | 0.20 | |
| Lifetime immunomodulators | 31 | 21 (67.7%) | 29 | 19 (65.5%) | 0.85 | |
| Lifetime months of immunomodulators | 31 | 18 (25) | 29 | 12 (18) | 0.51 | |
| Immunomodulators at enrollment | 31 | 21 (67.7%) | 32 | 19 (59.4%) | 0.49 | |
| Lifetime biologics | 31 | 6 (19.4%) | 30 | 4 (13.3%) | 0.53 | |
| Lifetime months of biologics | 31 | 1.5 (3.5) | 30 | 1.8 (6.1) | 0.58 | |
| Biologics at enrollment | 31 | 5 (16.1%) | 32 | 5 (15.6%) | 0.96 | |
| Lifetime extra-intestinal manifestations | 31 | 18 (58.1%) | 32 | 22 (68.8%) | 0.38 | |
| Lifetime co-morbidity | 31 | 12 (38.7%) | 32 | 18 (56.2%) | 0.16 | |
| Lifetime UGI granulomas in CD pts | 21 | 6 (28.6%) | 15 | 5 (30.6%) | 0.76 | |
| Lifetime complications in CD pts | 27 | 4 (14.8%) | 20 | 7 (35%) | 0.11 | |
| Disease severity at enrollment Inactive/Mild/Moderate-Severe (%) | 12/13/4 (41.4%/44.8%/13.8%) | 17/13/1 (54.8%/49.1%/3.2%) | 0.27 | |||
| ESR (mm/hr) | 26 | 20 (15) | 31 | 22 (17) | 0.74 | |
| Albumin (g/dL) | 30 | 3.9 (0.8) | 32 | 4 (0.4) | 0.49 | |
| CRP (mg/dL) | 29 | 0.77 (1.07) | 31 | 0.48 (0.68) | 0.19 | |
| HCT (%) | 31 | 38.1 (4) | 32 | 37.8 (3.9) | 0.76 | |
| WBC (Kcells/uL) | 31 | 7.1 (3.4) | 31 | 6.4 (3.3) | 0.31 | |
| PLTs (K cells/uL) | 31 | 361 (141) | 32 | 321 (122) | 0.18 | |
| Fe (mcg/dL) | 29 | 58.2 (34.7) | 32 | 83 (70.7) | 0.19 | |
| 25OHD (ng/mL) | 23 | 43.1 (22.5) | 23 | 29.7 (11) | 0.02 | |
| PTH (pg/mL) | 31 | 43.5 (21.6) | 31 | 37.1 (13.9) | 0.43 | |
| HABITS/NUTRITION/FHx 1 | ||||||
| Lifetime estrogen/contraceptives in girls | 14 | 3 (21.4%) | 14 | 1 (7.1%) | 0.28 | |
| Lifetime NG or P.O. supplements | 31 | 18 (40.6%) | 32 | 13 (51.8%) | 0.17 | |
| Lifetime smoking | 31 | 2 (6.5%) | 32 | 1 (3.1%) | 0.53 | |
| Lifetime alcohol use | 31 | 3 (9.7%) | 32 | 6 (18.8%) | 0.30 | |
| Family history of osteoporosis | 31 | 22 (71%) | 32 | 14 (43.8%) | 0.03 | |
| Total lifetime weight-bearing activity (hrs) | 31 | 2313 (2586) | 32 | 1853 (2063) | 0.79 | |
1
All at or by enrollment date, unless otherwise noted
DXA: dual energy X-Ray absorptiometry, SD: standard deviation, CD: Crohn disease, UC: ulcerative colitis, IBD: inflammatory bowel disease, Zlean (Ht): lean mass adjusted for height Z-score, Z%fat (age): % fat adjusted for age Z-score, ZTBBMD: Total body BMD Z-score, ZSBMD: Spine BMD Z-score, (BA): adjusted for bone age, UGI: upper gastrointestinal tract, ESR: erythrocyte sedimentation rate, CRP: C-reactive protein, PLTs: platelets, Fe: serum iron, 25OHD: serum twenty five hydroxy-vitamin D, PTH: serum parathyroid hormone, FHx; family history of osteoporosis, NG: nasogastric, P.O: per os