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Thorax 2000;55:375–382
EVect of one year treatment with inhaledfluticasone propionate or beclomethasonedipropionate on bone density and bonemetabolism: a randomised parallel group study inadult asthmatic subjects T C Medici, E Grebski, M Häcki, P Rüegsegger, C Maden, J Efthimiou, on behalf of aSwiss study group Abstract
longed treatment with high doses of inhaled Background—There is some concern that
corticosteroids may have a detrimental eVect prolonged treatment with high doses of
inhaled corticosteroids may have a detri-
mental eVect on bone mass. The aim of
this one year study was to investigate the
eVects of low and high doses of fluticasone
corticosteroids.3–10 However, most of these propionate (FP) (400 µg/day and 750 µg/
day) and beclomethasone dipropionate
sectional in design. In many cases, too, the (BDP) (800 µg/day and 1500 µg/day) on
results have been confounded by previous or bone mass and metabolism.
concomitant use of oral steroids or by other Methods—This was a multicentre, double
factors known to influence bone density such blind, parallel group study involving 69
mild to moderate asthmatic subjects who
markers of bone metabolism have also been were randomised to treatment as follows:
reported in normal subjects receiving inhaled 22 to FP400, 21 to BDP800, 13 to FP750,
corticosteroids over short periods.11–14 How- and 13 to BDP1500. Their mean age was 39
ever, the results from clinical studies are less years, 67% were men, and all the women
convincing. Whereas a few studies have found were premenopausal.
significant eVects on bone metabolism,15 16 Results—The results of peripheral quanti-
substantially more, including long term stud-ies, have reported no or only a small eVect.17 18 Department für Innere
computed
tomographic
Clearly, further long term research is needed to Medizin, Pneumologie
measurements (primary variable) showed
Universitätsspital,
investigate the eVects of inhaled corticosteroids that, compared with baseline values, there
Rämistrasse 100,
on both bone density and bone metabolism in was no loss of trabecular or integral (cor-
CH-8091 Zürich,
tical and trabecular) bone in the distal
Switzerland
Fluticasone propionate (FP) is a recently radius or tibia in any of the patients over
available inhaled corticosteroid19 with negligi- the 12 month study period. No consistent
ble oral bioavailability20 and therefore a re- pattern emerged from the analysis of
Gubelhangstrasse 6,
duced potential for systemic eVects. A number changes from baseline in markers of bone
8050 Zürich,
of clinical studies have shown that FP has an formation and resorption after six and 12
Switzerland
months of treatment.
with other inhaled corticosteroids,21 and at half Conclusion—The results of this study pro-
the microgram dose is at least as eVective as Biomedizinische
vide reassuring prospective one year data
Technik und
showing that inhaled corticosteroids, in
Medizinische
the range of doses used, had no adverse
Informatik,
The aim of this study was to investigate pro- Universität Zürich,
Vects on bone mass and metabolism in spectively and compare the eVects of treatment
Switzerland
this group of asthmatic patients.
with low and high doses of inhaled FP and (Thorax 2000;55:375–382)
BDP over a one year period on BMD and bio-chemical markers of bone metabolism in adult Respiratory Clinical
Keywords: fluticasone propionate; inhaled cortico- Research, Glaxo
steroids; bone mineral density; bone metabolism; patients with moderately severe asthma.
Wellcome R&D,
Stockley Park, UK
Prolonged treatment with oral corticosteroids Patients with mild to moderate asthma were is associated with a reduction in bone density, recruited from the outpatient departments of osteoporosis, and a risk of fractures.1 Inhaled seven centres in Switzerland. The age limit was corticosteroids have provided a major break- 20–55 years for men and 20–45 years for through in the treatment of asthma, producing women (premenopausal). For the six months improvements in symptoms and lung function preceding the start of the study patients had without the risk of serious side eVects com- been receiving regular treatment with inhaled monly associated with oral corticosteroids.
corticosteroids in doses ranging from 400 to There is some concern, however, that pro-

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