Bones and Crohn’s: No benefit of adding sodium fluoride or ibandronate to calcium and vitamin D

Table 1 Baseline characteristics (mean ± SD) n (%)

	Group A calcium/vitamin D	Group B0/1 + sodium fluoride	Group C0/1 + ibandronate
No. of patients	32	62	54
Male/female	14/18	29/33	27/27
Age (yr)	33.8 ± 9.76	35.7 ± 12.8	36.8 ± 13.1
Duration of disease (yr)	7.4 ± 1.7	9.4 ± 2.1	8.1 ± 1.9
Smoking	13 (40.6)	23 (37.1)	19 (35.2)
Postmenopausal	0	2	1
Extent of disease
Ileal disease	11 (34.4)	20 (32.3)	21 (38.9)
Colonic disease	5 (15.6)	8 (12.9)	7 (13)
Ileocolonic disease	16 (50.0)	34 (54.8)	26 (48.1)
Bowel resection
No bowel resection	18 (56.2)	39 (62.9)	29 (53.7)
Ileal resection	8 (25.0)	12 (19.4)	14 (25.9)
Colonic resection	2 (6.2)	5 (8.1)	4 (7.4)
Ileocolonic resection	4 (12.6)	6 (9.7)	7 (13)
Patients with bowel resection during study	4	6	5
Use of corticosteroids
No previous use	3 (9.4)	6 (9.7)	6 (11.1)
Cumulative dose < 10 g	22 (68.8)	36 (58.1)	34 (63)
Cumulative dose > 10 g	7 (21.8)	28 (32.2)	14 (25.9)
Body weight (kg)	69.4 ± 15.51	63.71 ± 11.9	64.8 ± 13.91
Body height (cm)	172 ± 7.63	170 ± 8.8	170 ± 9.0
BMI (kg/m2)	23.54 ± 5.34	22.01 ± 3.6	22. 4 ± 3.92
CDAI	141.5 ± 100.96	145 ± 95.5	135.9 ± 85.03
T-score spine	-1.57 ± 0.31	-1.82 ± 0.75	-1.89 ± 0.71
BMD spine (g/cm2)	0.90 ± 0.04	0.87 ± 0.09	0.85 ± 0.08
Pre-existing vertebral fractures1	6 (22.2) of patients with 10 fractures	9 (19.2) of patients with 18 fractures	14 (28.6) of patients with 28 fractures

¹Intention to treat (ITT) analysis. BMI: Body mass index; CDAI: Crohn’s disease activity index; BMD: Bone mineral density.

Table 2 Bone mineral density of spine and femur, in- and between-group change

Lumbar spine		Baseline		First year		Second year		Third year
Group A calcium/vitamin D	n (%)	32		27 (84.4)		22 (68.6)		14 (43.8)
	T-score	-1.57 ± 0.31		-1.32 ± 0.42b		-1.21 ± 0.49b		-1.18 ± 0.36b
	Δ T-score (95% CI)		+0.28 ± 0.35 (0.162–0.460)		+0.33 ± 0.49 (0.109-0.558)		+0.43 ± 0.47 (0.147–0.708)
	BMD	0.90 ± 0.04		0.92 ± 0.05		0.94 ± 0.05		0.94 ± 0.04
Group B + sodium fluoride	n (%)	62		47 (75.8)		36 (58.0)		30 (48.4)
	T-score	-1.82 ± 0.75h		-1.60 ± 0.84d		-1.40 ± 1.01d		-1.37 ± 0.95d
	Δ T-score (95% CI)		+0.22 ± 0.33 (0.125–0.321)		+0.47 ± 0.60 (0.262–0.676)		+0.51 ± 0.44 (0.338–0.682)
	BMD	0.87 ± 0.08		0.88 ± 0.09		0.90 ± 0.11		0.91 ± 0.11
Group C + ibandronate	n (%)	54		49 (90.1)		34 (63.0)		27 (50)
	T-score	-1.89 ± 0.71		-1.69 ± 0.78e		-1.61 ± 0.83e		-1.56 ± 0.78f
	Δ T-score (95% CI)		+0.22 ± 0.38 (0.111– 0.329)		+0.36 ± 0.53 (0.147–0.578)		+0.41 ± 0.48 (0.238–0.576)
	BMD	0.85 ± 0.08		0.87 ± 0.08		0.89 ± 0.08		0.90 ± 0.08
Total	n (%)	148		123 (83.1)		92 (62.2)		71 (47.8)

In-treatment group change, baseline to first, second and third year: Group A, ^bP < 0.01; group B, ^dP < 0.01; group C, ^eP < 0.025, ^fP < 0.01; Between-treatment groups: ^hP < 0.01, group A vs group C. BMD: Bone mineral density.

Table 3 Bone mineral density of the lumbar spine, in- and between-group change (intention-to-treat)

Lumbar spine	Baseline	End of study	Δ
Group A (n = 27)
T-score	-1.57 ± 0.31	-1.20 ± 0.46b	+0.38 ± 0.46
BMD	0.9 ± 0.04	0.94 ± 0.06	+0.04 ± 0.05
Follow-up (yr)	2.58 ± 1.0
Group B (n = 47)
T-score	-1.82 ± 0.40	-1.43 ± 0.62b	+0.37 ± 0.50
BMD	0.87 ± 0.05	0.91 ± 0.06	+0.04 ± 0.05
Follow-up (yr)	2.92 ± 0.89
Group C (n = 49)
T-score	-1.91 ± 0.40	-1.56 ± 0.56b	+0.35 ± 0.49
BMD	0.86 ± 0.04	0.90 ± 0.66	+0.04 ± 0.05
Follow-up (yr)	2.44 ± 1.17

^bP < 0.01. BMD: Bone mineral density.

Table 4 Prevalence and incidence of vertebral fractures

	All patients	Group A calcium/vitamin D	Group B + sodium fluoride	Group C + ibandronate
No. of patients	123	27	47	49
Patients with fractures, n (%)	29 (23.6)	6 (22.2)	9 (19.2)	14 (28.6)
No. of fractures	56	10	18	28
New fractures (n)	1	0	1	0
T-score lumbar spine	-1.80 ± 0.34	-1.57 ± 0.31	-1.82 ± 0.40	-1.91 ± 0.04
BMD lumbar spine (g/cm2)	0.87 ± 0.05	0.90 ± 0.04	0.87 ± 0.05	-0.86 ± 0.04
Follow-up (yr)	2.65 ± 1.00	2.58 ± 1.00	2.92 ± 0.89	2.44 ± 1.17

BMD: Bone mineral density.