Ursodeoxycholic acid (UDCA) has been proposed as beneficial therapy fo
r patients with primary biliary cirrhosis (PBC). The effects of UDCA o
n metabolic bone disease, a major source of morbidity in patients with
PBC, are essentially unknown. Preliminary information suggests that U
DCA may improve biochemical indices of bone disease, although informat
ion about the effects of UDCA on bone density is lacking. In this stud
y, we describe the effects of UDCA on lumbar spine bone mineral densit
ies over a 3-year period durin:: which patients were enrolled in a ran
domized, double-blind, therapeutic trial of UDCA Cor the treatment of
PBC. Lumbar spine dual-photon densitometry was measured at entry and a
nnually. Eighty-eight patients, 50 in the UDCA group and 38 In the pla
cebo group, had serial measurements available for up to 3 years. There
was no statistical difference between the two treatment groups at ent
ry with respect to histological stage, total bilirubin, age, use of ca
lcium supplement, vitamin D levels, or estrogen. After 3 years of trea
tment, there was no significant difference in the lumbar spine bone de
nsitometry measurements between the UDCA-treated and placebo groups. W
e conclude that, after 3 years of treatment, UDCA is not associated wi
th statistically significant differences in the rate of bone loss from
the lumbar spine iu patients when compared with placebo despite benef
icial effects of treatment on the underlying liver disease. Further ef
forts to define effective treatments for the bone disease need to be p
ursued.