Effects of statins on biomarkers of bone metabolism: A randomised trial

Background and Aim: Recently several studies have indicated there may be di fferences among statins regarding a possible association between therapy an d a reduction in risk of fractures. No data from prospective randomised cli nical trials designed to assess either biochemical or clinical effects on b one metabolism are yet available. We assayed levels of biochemical markers of bone formation in stored serum samples from a recently completed randomi sed clinical trial conducted to compare the effects of simvastatin and ator vastatin oil the lipid profile of patients with hypercholesterolaemia. Methods and Results: This 12-week, randomised, multicenter, open-label stud y was designed to compare the safe ty and lipid-lowering efficacy of simvas tatin 40 mg or 80 mg with that of atorvastatin 20 mg or 40 mg in 846 hyperc holesterolaemic patients. Stored serum samples from this study were analyse d to compare the effects of simvastatin and atorvastatin on 2 biomarkers of bone turnover bone-specific alkaline phosphatase (BSAP), a marker of bone formation, and C-teleopeptide of type 1 collagen (CTx), a marker of bone re sorption. Treatment with simvastatin 40 and 80 mg/day, but not atorvastatin 20 and 40 mg/day, led to significant (p < 0.05) reductions in BSAP in both men (4.1-5.4% reduction) and women (4.2-7.4% reduction). In addition, ther e appeared to be a dose-dependent effect with greater reductions in BSAP se en with the 80 mg dose of simvastatin. Treatment with either 20 mg or 40 mg of atorvastatin had no significant effect on BSAP levels on the groups as a whole or in the gender-specific subgroups. CTx showed a small, bur nor st atistically significant, decrease with simvastatin, again with an apparent dose-related trend. Atorvastatin treatment generally resulted in small, non significant increases in CTx. Conclusions: The present serum bone biomarker results show that treatment w ith simvastatin, brit not atorvastatin, decreases BSAP and suggest that sim vastatin may have a beneficial effect on bone turnover. (C) 2001, Medical P ress.