Zein CO et al. (2005) Alendronate improves bone mineral density in primary biliary cirrhosis: a randomized placebo-controlled trial. Hepatology 42: 762–771

Numerous studies have established a link between primary biliary cirrhosis (PBC) and loss of bone mass; however, a specific treatment regimen to improve bone mineral density (BMD) in such patients has yet to be established. Alendronate, a bisphosphonate effective in improving the BMD of postmenopausal women, has yet to be widely investigated in PBC patients. Zein and colleagues therefore conducted a randomized, placebo-controlled trial to evaluate the efficacy of alendronate in improving the BMD of PBC patients.

The trial enrolled 34 PBC patients (32 postmenopausal women and 2 men), with a mean age of 61 years, who were randomly assigned 1:1 to receive either oral alendronate 70 mg/week or placebo, for 1 year.

Patients in the alendronate group showed significantly greater improvement in BMD, compared with the placebo group, at 1 year of follow-up. The improvement was greater than that observed in previous studies. Markers of bone formation and resorption decreased significantly with alendronate compared with placebo; however, the decrease was less than expected from previous studies. The presence of advanced liver disease in over half of the alendronate patients might have affected the accuracy of these markers. The rate of adverse events did not differ significantly between the treatment and placebo groups; hepatotoxicity caused by alendronate was not observed, although the study was too small to evaluate adverse events conclusively.

The authors conclude that alendronate is well tolerated and effective in increasing the BMD of PBC patients, and call for studies involving a larger patient population.