CYCLIC ETIDRONATE IN THE PREVENTION OF BONE LOSS IN CORTICOSTEROID-TREATED PRIMARY BILIARY-CIRRHOSIS - A PROSPECTIVE, CONTROLLED PILOT-STUDY

Background: Recently, promising disease modifying effects of low dose corticosteroid treatment in primary biliary cirrhosis have been report ed. However, steroid-induced bone loss constitutes a potential drawbac k of this treatment option. Aim: To assess whether etidronate can redu ce bone loss during corticosteroid treatment. Methods: Twelve primary biliary cirrhosis patients (all Child-Pugh Class A), treated with pred nisone in the context of a 1-year placebo-controlled pilot study with prednisone (maintenance dose 10 mg daily), and azathioprine (50 mg dai ly), were randomized to receive either cyclical etidronate (400 mg dai ly, during 2 weeks) alternated with calcium 500 mg daily during 11 wee ks or calcium alone. All patients had been receiving ursodeoxycholic a cid during at least 1 year and this treatment was continued. Bone mass was measured in the lumbar spine and the femoral neck by dual energy X-ray absorptiometry before and after 3 and 12 months of treatment, Ma rkers of bone formation (serum osteocalcin, procollagen-I-propeptide) and bone resorption (urinary deoxypyridinoline and calcium) were also monitored. Results: The mean lumbar bone mineral density did not signi ficantly change in the patients taking etidronate+calcium, in contrast to patients treated with calcium alone (+0.4 vs. -3.0%; p=0.01). Chan ges in femoral bone mineral density and markers of bone turnover did n ot significantly differ between both groups, No adverse effects of eti dronate were noted. Conclusions: Cyclical etidronate appears to preven t bone loss associated with prednisone treatment in patients with prim ary biliary cirrhosis. These preliminary results encourage the further evaluation of long term prednisone treatment and concurrent bisphosph onate therapy in primary biliary cirrhosis.