A randomized, double-blind study comparing the effects of beclomethasone and fluticasone on bone density over two years

Cross-sectional studies have suggested that asthmatic patients receiving hi gh dose inhaled corticosteroids and intermittent courses of oral corticoste roids have reduced bone mass. This prospective 2-yr study was undertaken to evaluate changes in bone density of patients receiving high doses of inhal ed corticosteroids, Patients (n=33) (males aged 18-50 yrs, females aged 18-40 yrs) on inhaled c orticosteroids 1,000-2,000 mu g.day(-1) were randomized in a double-blind f ashion to either fluticasone propionate (FP) 1,000 mu g.day(-1) or beclomet hasone dipropionate (BDP) 2,000 mu g.day(-1): In parallel, three open centr al groups of the same age range were studied: asthmatics (n=8) receiving Lo w dose inhaled corticosteroids (less than or equal to 400 mu g.day(-1)) (gr oup A); chronic, severe asthmatics (n=8) receiving oral corticosteroids (gr eater than or equal to 10 mg day) (group B); and healthy untreated voluntee rs (n=7) (group C), Bone densitometry scans (quantitative computed tomograp hy (QCT) of spine; dual X-ray absorptiometry of spine, femoral neck, and si ngle photon absorptiometry of forearm) were performed at baseline and after 6, 12 and 24 months of treatment. Biochemical bone marker measurements (se rum osteocalcin, bone alkaline phosphatase, pro-collagen type 1 carboxy ter minal propeptide, deoxypyridinoline and C-telopeptide of type 1 collagen) w ere collected every 3 months. Fifteen FP (mean age 36 yrs, six male) and 9 BDP patients (mean age 33 yrs, five male); completed the study, At 0 months, mean bone mineral density (B MD) was lower in patients receiving inhaled corticosteroids (both low dose and high dose) than in normal volunteers. In the FP-treated group, mean ver tebral trabecular BMD quantitative computed tomography remained stable with no evidence of decline, whereas there was some decline in the BDP-treated group. The treatment difference between FP and BDP was statistically signif icant in favour of FP for quantitative computed tomography measurements aft er 12 months (p=0.006) and 24 months (p=0.004), This study suggests that over 24 months, changes in bone density are minima l in patients on high-dose inhaled corticosteroids.