title: Effects of mometasone, fluticasone, and montelukast on bone mineral density in adults with asthma.
abstract: 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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Fundación Cidea Allergy and Respiratory Research Unit, Buenos Aires, Argentina. Electronic address: maspero@ciudad.com.ar.
authors.forename: Jorge
authors.initials: J
authors.lastname: Maspero
authors.affiliation: Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.
authors.forename: Vibeke
authors.initials: V
authors.lastname: Backer
authors.affiliation: Merck Research Laboratories, Merck & Co Inc, Whitehouse Station, NJ.
authors.forename: Ruji
authors.initials: R
authors.lastname: Yao
authors.affiliation: Merck Research Laboratories, Merck & Co Inc, Whitehouse Station, NJ.
authors.forename: Heribert
authors.initials: H
authors.lastname: Staudinger
authors.affiliation: Merck Research Laboratories, Merck & Co Inc, Whitehouse Station, NJ.
authors.forename: Ariel
authors.initials: A
authors.lastname: Teper
mesh_terms: D000085:Acetates / Q000008:administration & dosage*; D000280:Administration, Inhalation; D000284:Administration, Oral; D000328:Adult; D000730:Androstadienes / Q000008:administration & dosage*; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D015519:Bone Density / Q000187:drug effects*; D003521:Cyclopropanes; D004311:Double-Blind Method; D058995:Dry Powder Inhalers; D005260:Female; D005269:Femur; D000068298:Fluticasone; D006801:Humans; D008297:Male; D000068656:Mometasone Furoate; D011244:Pregnadienediols / Q000008:administration & dosage*; D011804:Quinolines / Q000008:administration & dosage*; D013440:Sulfides; D013607:Tablets
chemical_list: D000085:Acetates; D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D011244:Pregnadienediols; D011804:Quinolines; D013440:Sulfides; D013607:Tablets; D000068656:Mometasone Furoate; D000068298:Fluticasone; C093875:montelukast
keywords: Asthma; Bone mineral density; Inhaled corticosteroids; Lumbar spine