Osteoporosis in primary biliary cholangitis

Table 1 Summary of results in randomized-controlled trials of active agent vs placebo or no treatment

Agent	Treatment	No. of patients (n)	BMD changes at 1 yr (%)	BMD changes at 2 yr (%)	Fractures (n)
Etidronate	400 mg/d (3 mo cycles)	6 (etidronate)	+1.0 (L), +0.2 (F)	N/A	0
Wolfhagen et al[43], 1997		6 (no treatment)3	-1.7 (L), +0.4 (F)		0
Lindor et al[6], 2000	400 mg/d (3 mo cycles)	29 (etidronate)	+0.7 (L), +1.3 (F)	+1.0 (L), +0.5 (F)	4 (V)
		31 (placebo)	-0.6 (L), +0.9 (F)	+2.6 (L), +0.8 (F)	4 (V)
Alendronate	70 mg/wk	15 (alendronate)	+10.4 (L)12, +1.4 (F)1	N/A	1 (V), 0 (P)
Zein et al[44], 2005		13 (placebo)	-0.1 (L)1, -2.1 (F)1		0 (V), 1 (P)
HRT	50 mcg twice weekly TD estradiol + 2.5 mg/d progestin	8 (HRT)	+3.1 (L)2, +1.7 (F)12	N/A	0
Ormarsdottir et al[51], 2004		9 (no treatment)3	+1.0 (L), -0.6 (F)1		0
Boone et al[9], 2006	0.05 mg/d TD estradiol + 0.25 mg/d TD progestin	8 (HRT)	N/A	-0.6 (L), +0.2 (F)	0 (V)
		14 (placebo)		-0.8 (L), -3.7 (F)2	2 (V)
Sodium fluoride	50 mg/d sodium fluoride	8 (fluoride)	N/A	+2.9 (L)1	0
Guañabens et al[7], 1992		8 (placebo)		-6.6 (L)12	0
Calcitriol	0.5 mcg/d BID calcitriol	17 (calcitriol)	+0.1 (L)1	N/A	N/A
Shiomi et al[38], 1999		17 (no treatment)3	-3.1 (L)1
Vitamin K	45 mg/d vitamin K2	15 (vitamin K)	+0.3 (L)1	-0.8 (L)1	N/A
Nishiguchi et al[57], 2001		15 (no treatment)3	-3.5 (L)1	-6.9 (L)1

¹Statistical significance (P < 0.05) between groups;

²Statistical difference (P < 0.05) from baseline;

³Patients in no treatment groups received vitamin D and calcium supplementation. L: Lumbar; F: Femoral; V: Vertebral; P: Peripheral; BMD: Bone mineral density.

Table 2 Summary of results in comparative randomized controlled trials of different agents for treatment of osteoporosis in primary biliary cholangitis

Agent	Treatment	No. of patients (n)	BMD changes at 1 yr (%)	BMD changes at 2 yr (%)	Fractures (n)
Guañabens et al[39], 1997
Etidronate	400 mg/d (3 mo cycles)	13 (etidronate)	-0.1 (L), -0.4 (F)	+0.5 (L)2, -0.2 (F)	0 (V), 3 (P)
Sodium fluoride	50 mg/d sodium fluoride	10 (fluoride)	-1.7 (L), -0.6 (F)	-2.1 (L), -1.5 (F)	2 (V), 2 (P)
Guañabens et al[45], 2003
Alendronate	10 mg/d	13 (alendronate)		+5.8 (L)12, +3.9 (F)12	0 (V), 2 (P)
Etidronate	400 mg/d (3 mo cycles)	13 (etidronate)		+1.9 (L)1, +0.4 (F)1	0 (V), 1 (P)
Guañabens et al[2], 2005
Alendronate	10 mg/d	16 (alendronate)	+3.3 (L)2, +1.2 (F)2
Alendronate	70 mg/wk	10 (alendronate)	+1.2 (L), -0.3 (F)
Guañabens et al[46], 2013
Ibandronate	150 mg/mo	14 (ibandronate)	+3.8 (L), +1.0 (F)	+5.7 (L)2, +1.1 (F)	0 (V), 0 (P)
Alendronate	70 mg/wk	19 (alendronate)	+4.6 (L), +1.4 (F)	+4.5 (L)2, +2.5 (F)	1 (V), 0 (P)

¹Statistical significance (P < 0.05) between groups;

²Statistical difference (P < 0.05) from baseline. L: Lumbar; F: Femoral; V: Vertebral; P: Peripheral; BMD: Bone mineral density.