Baseline demographics, disease characteristics and comorbidities, concomitant medication, and laboratory parameters
| FDI (N=48) | FCM (N=49) | Total (N=97) | |
| Patient demographics | |||
| Age, years | 42.3 (14.1) | 41.9 (14.7) | 42.1 (14.4) |
| Sex | |||
| Female | 26 (54.2%) | 25 (51.0%) | 51 (52.6%) |
| Male | 22 (45.8%) | 24 (49.0%) | 46 (47.4%) |
| Race | |||
| Asian | 6 (12.5%) | 4 (8.2%) | 10 (10.3%) |
| White | 39 (81.3%) | 44 (89.8%) | 83 (85.6%) |
| Other | 3 (6.3%) | 1 (2.0%) | 4 (4.1%) |
| Weight, kg | 79.8 (15.4) | 80.6 (16.6) | 80.2 (15.9) |
| BMI, kg/m2 | 27.7 (5.5) | 27.5 (5.2) | 27.6 (5.3) |
| Disease characteristics and comorbidities | |||
| IBD diagnosis | |||
| Crohn’s disease | 16 (33.3%) | 22 (44.9%) | 38 (39.2%) |
| Ulcerative colitis | 32 (66.7%) | 27 (55.1%) | 59 (60.8%) |
| Disease activity status | |||
| Harvey-Bradshaw Index (Crohn’s disease) | 3.6 (2.4) | 3.8 (3.1) | 3.7 (2.8) |
| Partial Mayo Score (ulcerative colitis) | 2.9 (2.4) | 2.6 (2.3) | 2.8 (2.3) |
| FACIT Fatigue Scale score | 22.1 (10.2) | 27.4 (12.8) | 24.8 (11.9) |
| Laboratory parameters | |||
| Hb, g/L | 105 (15) | 104 (14) | 105 (14) |
| Ferritin, ng/mL | 9.5 (9.6) | 14.6 (28.7) | 12.1 (21.5) |
| TSAT, % | 9.3 (8.4) | 7.1 (4.4) | 8.2 (6.7) |
| Phosphate, mg/dL | 3.5 (0.6) | 3.5 (0.6) | 3.5 (0.6) |
| Urinary fractional excretion of phosphate, % | 7.6 (3.1) | 9.4 (6.1) | 8.5 (4.9) |
| iFGF23, pg/mL | 46.6 (23.3) | 48.5 (22.9) | 47.6 (23.0) |
| Ionised calcium, mg/dL | 5.1 (0.2) | 5.1 (0.2) | 5.1 (0.2) |
| Intact PTH, pg/mL | 54.9 (28.3) | 61.4 (46.6) | 58.2 (38.6) |
| 25-hydroxyvitamin D, ng/mL | 22.9 (10.2) | 23.7 (11.8) | 23.3 (11.0) |
| 1,25-dihydroxyvitamin D, pg/mL | 46.6 (14.8) | 51.8 (19.9) | 49.2 (17.7) |
| 24,25-dihydroxyvitamin D, ng/mL | 2.3 (1.7) | 2.3 (1.8) | 2.3 (1.8) |
| ALP, U/L | 75.9 (34.8) | 73.1 (29.4) | 74.5 (32.0) |
| Bone-specific ALP, μg/L | 10.8 (3.6) | 12.4 (6.4) | 11.6 (5.2) |
| N-terminal P1NP, ng/mL | 50.6 (19.8) | 74.9 (66.4) | 62.9 (50.4) |
| CTx, ng/mL | 0.3 (0.2) | 0.4 (0.3) | 0.4 (0.2) |
| CRP, mg/L | 9.5 (13.5) | 13.3 (30.8) | 11.4 (23.8) |
| Concomitant medication | |||
| Biologic therapy* | 20 (41.7%) | 21 (42.9%) | 41 (42.3%) |
| Interleukin inhibitors | 2 (4.2%) | 7 (14.3%) | 9 (9.3%) |
| TNF-α inhibitors | 16 (33.3%) | 16 (32.7%) | 32 (33.0%) |
| Vedolizumab | 6 (12.5%) | 5 (10.2%) | 11 (11.3%) |
| Glucocorticoids | 6 (12.5%) | 3 (6.1%) | 9 (9.3%) |
| Anti-resorptive therapy† | 4 (8.3%) | 1 (2.0%) | 5 (5.2%) |
| Vitamin D supplements | 6 (12.5%) | 10 (20.4%) | 16 (16.5%) |
| Vitamin D, calcium supplements | 21 (43.8%) | 19 (38.8%) | 40 (41.2%) |
Data are n (%) or mean (SD), and are presented for the safety analysis set.
*Interleukin inhibitors, TNF-α inhibitors, vedolizumab.
†Bisphosphonates.
ALP, alkaline phosphatase; BMI, body mass index; CRP, C-reactive protein; CTx, C-terminal collagen crosslinks; FACIT, Functional Assessment of Chronic Illness Therapy; FCM, ferric carboxymaltose; FDI, ferric derisomaltose; Hb, haemoglobin; IBD, inflammatory bowel disease; iFGF23, intact fibroblast growth factor 23; P1NP, propeptide of type one collagen; PTH, parathyroid hormone; TNF, tumour necrosis factor; TSAT, transferrin saturation.