Bone loss is a well-recognized complication of primary biliary cirrhosis.
It has been suggested that alendronate might improve bone mineral density in primary biliary cirrhosis.
However, no randomized placebo-controlled trial has been conducted.
Dr Keith Lindor and colleagues from Minnesot compared the effects of alendronate versus placebo on bone mineral density.
The team also assessed the effects of alendronate on biochemical measurements of bone turnover in patients with primary biliary cirrhosis-associated bone loss.
The investigators conducted a double-blinded, randomized, placebo-controlled trial.
The investigative team enrolled 34 patients with a primary biliary cirrhosis and bone mineral density t score of less than -1.5 were included.
|After 1 year, there was an improvement in spine bone mineral density with alendronate|
The patients were randomized to 70 mg per week of alendronate or placebo over 1 year, with 17 in each arm.
The team measured bone mineral density of the lumbar spine and proximal femur at entry and at 1 year.
The investigators assessed changes from baseline in bone mineral density and biochemical measurements of bone turnover.
After 1 year, the team found a significantly larger improvement in spine bone mineral density in the alendronate group compared with the placebo group.
The investigators also observed a larger improvement in the femoral bone mineral density of alendronate patients versus placebo.
Bone mineral density changes were found to be independent of concomitant estrogen therapy.
The team noted that the rate of adverse effects was similar in both groups.
Dr Lindor's team commented, “In patients with primary biliary cirrhosis-related bone loss, alendronate significantly improves bone mineral density compared with placebo.”
“Although in this study oral alendronate appears to be well tolerated in patients with primary biliary cirrhosis, larger studies are needed to formally evaluate safety.”