Etidronate for osteoporosis in primary biliary cirrhosis: a randomized trial

Background/Aim: Osteoporosis is a common complication of primary biliary ci rrhosis but there is no accepted therapy for the osteoporosis. In this rand omized controlled trial, we compared the effects of etidronate to placebo o n the treatment of osteoporosis associated with primary biliary cirrhosis. Methods: Sixty-seven patients with primary biliary cirrhosis and osteopenia , defined by bone mineral density criteria (T-score < -2.0) were enrolled. Measurements of the lumbar spine and proximal femur, as well as x-rays of t he lumbar spine, were obtained, Patients received cyclical etidronate 400 m g/day for 14 days every 3 months for at least 1 year. Supplemental calcium was administered on the days patients did not receive etidronate. Results: Of the 67 patients entered, 60 completed at least 1 year of therap y. There was no significant difference in changes in bone density at either the lumbar spine or femur in patients receiving etidronate when compared t o placebo, Fractures occurred in eight patients, four receiving etidronate, Etidronate therapy was associated with a significant reduction in markers of bone turnover compared to placebo, These changes did not correlate with changes in bone density. Conclusions: Cyclical etidronate administered with supplemental calcium did not significantly improve bone density in patients with primary biliary ci rrhosis.