One year prospective open study of the effect of high dose inhaled steroids, fluticasone propionate, and budesonide on bone markers and bone mineral density

Background-Inhaled corticosteroids are recognised as the most effective age nts in the treatment of asthma. However, concerns have been expressed about the effects of high doses of inhaled corticosteroids on safety in relation to bone resorption and formation. This study measures the effects of two i nhaled corticosteroids on bone markers and bone mineral density (BMD) over one year. Methods-A one year randomised, prospective, open parallel study comparing i nhaled fluticasone propionate (FP), 500 mu g twice daily in 30 patients, an d budesonide (BUD), 800 mu g twice daily in 29 patients, delivered by meter ed dose inhaler and large volume spacers was performed in adults with moder ate to severe asthma. Biochemical markers of bone turnover (osteocalcin, pr ocollagen type 1 C-terminal propeptide (PICP), immunoreactive free deoxypyr idinoline (iFDpd), N-terminal crosslinked telopeptides of type I collagen ( NTx)), BMD at the spine and femoral neck, and serum cortisol concentrations were measured at baseline and 12 months later. Results There were no significant differences between the inhaled steroids on bone markers of bone resorption and formation or bone mineral density. B one mineral density of the spine increased slightly in both groups over the 12 month period. Serum osteocalcin levels increased from baseline in both treatment groups (FP 16.9%, p = 0.02; BUD 14.3%, p = 0.04). PICP did not di ffer significantly from baseline. Both markers of bone resorption (iFDpd, N Tx) varied considerably with no significant changes after one year. There w as a significant correlation in percentage change from baseline between BMD of the spine and osteocalcin at resorption measures 12 months (r = 0.4, p = 0.017). Mean serum cortisol levels remained within the normal range in bo th groups following treatment. Conclusion-There was no evidence of a decrease in BMD during 12 months of t reatment with high doses of either FP or BUD. The change in spine BMD corre lated with the increase in osteocalcin. Studies extending over several year s are needed to establish whether these findings persist.