Effect of one year treatment with inhaled fluticasone propionate or beclomethasone dipropionate on bone density and bone metabolism: a randomised parallel group study in adult asthmatic subjects

Background-There is some concern that prolonged treatment with high doses o f inhaled corticosteroids may have a detrimental effect on bone mass. The a im of this one year study was to investigate the effects of low and high do ses of fluticasone propionate (FP) (400 mu g/day and 750 mu g/day) and becl omethasone dipropionate (BDP) (800 mu g/day and 1500 mu g/day) on bone mass and metabolism. Methods-This was a multicentre, double blind, parallel group study involvin g 69 mild to moderate asthmatic subjects who were randomised to treatment a s follows: 22 to FP400, 21 to BDP800, 13 to FP750, and 13 to BDP1500. Their mean age was 39 years, 67% were men, and all the women were premenopausal. Results-The results of peripheral quantitative computed tomographic (pQCT) measurements (primary variable) showed that, compared with baseline values, there was no loss of trabecular or integral (cortical and trabecular) bone in the distal radius or tibia in any of the patients over the 12 month stu dy period. No consistent pattern emerged from the analysis of changes from baseline in markers of bone formation and resorption after six and 12 month s of treatment. Conclusion-The results of this study provide reassuring prospective one yea r data showing that inhaled corticosteroids, in the range of doses used, ha d no adverse effects on bone mass and metabolism in this group of asthmatic patients.