Effects of mometasone, fluticasone, and montelukast on bone mineral density in adults with asthma.

Background: Associations of inhaled corticosteroids (ICS) with bone mineral density (BMD) loss have not been characterized consistently.

Objective: This randomized, double-blind study assessed effects of mometasone furoate (MF) administered via dry powder inhaler on BMD of patients with persistent asthma.

Methods: Adults with mild-moderate persistent asthma who did not receive ICS for ≥3 months were randomized to MF 400 μg once daily (QD) in the evening (pm), MF 200 μg QD pm, montelukast sodium (ML) 10 mg QD pm, or fluticasone propionate (FP) 250 μg twice daily. Included patients had 25-hydroxy vitamin D levels ≥15 ng/mL at baseline. All the patients received calcium and vitamin D supplements for daily use during the trial. Duplicate BMD scans were done at baseline, 6 months, and 1 year. The mean percentage change in lumbar spine (LS) BMD from baseline to end point for MF 400 μg versus ML 10 mg was the primary analysis. Changes from baseline in left total femur BMD and femoral neck BMD were secondary assessments.

Results: At the end point, mean LS BMD increased 0.9% (MF 400 μg), 1.2% (ML), 0.7% (MF 200 μg), and 1.1% (FP), with no significant differences for MF 400 μg versus ML (-0.3% [95% CI, -1.01 to 0.27]) for LS BMD. No significant differences among treatments occurred for changes in left total femur BMD; all were slight increases. Changes in femoral neck BMD were 0.4% (MF 400 μg), -0.2% (ML), -0.2% (MF 200 μg), and -0.4% (FP); only the difference between MF 400 μg and FP was statistically significant (P = .044).

Conclusion: No detrimental effects on lumbar BMD were observed after up to 1 year of treatment with MF in comparison with ML for patients who received calcium and vitamin D supplements.