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 of inhaled corticosteroids may have a detrimental effect on bone mass. The aim of this one year study was to investigate the effects of low and high doses of fluticasone propionate (FP) (400 microg/day and 750 microg/day) and beclomethasone dipropionate (BDP) (800 microg/day and 1500 microg/day) on bone mass and metabolism.


METHODS
This was a multicentre, double blind, parallel group study involving 69 mild to moderate asthmatic subjects who were randomised to treatment as 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 study period. No consistent pattern emerged from the analysis of changes from baseline in markers of bone formation and resorption after six and 12 months of treatment.


CONCLUSIONS
The results of this study provide reassuring prospective one year data showing that inhaled corticosteroids, in the range of doses used, had no adverse effects on bone mass and metabolism in this group of asthmatic patients.
Medici
T C
TC
Department für Innere Medizin, Pneumologie Universitätsspital, Rämistrasse 100, CH-8091 Zürich, Switzerland.
Grebski
E
E
Häcki
M
M
Rüegsegger
P
P
Maden
C
C
Efthimiou
J
J
D000280:Administration, Inhalation; D000287:Administration, Topical; D000328:Adult; D000730:Androstadienes / Q000494:pharmacology*; D018927:Anti-Asthmatic Agents / Q000494:pharmacology*; D000893:Anti-Inflammatory Agents / Q000494:pharmacology*; D001249:Asthma / Q000188:drug therapy / Q000503:physiopathology; D001507:Beclomethasone / Q000494:pharmacology*; D015415:Biomarkers / Q000032:analysis; D015519:Bone Density / Q000187:drug effects*; D001842:Bone and Bones / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D005938:Glucocorticoids; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D000893:Anti-Inflammatory Agents; D015415:Biomarkers; D005938:Glucocorticoids; D000068298:Fluticasone; D001507:Beclomethasone