title: Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study.
abstract: BACKGROUND
  Osteoporosis is common in patients with COPD, but its prevalence and progression are not well characterized. Concerns have been raised over the possible deleterious effect of long-term therapy with inhaled corticosteroids (ICSs) on bone density in this population. Here, we investigated the long-term effects of therapy with fluticasone propionate (FP) alone, salmeterol (SAL) alone, and a SAL/FP combination (SFC) on bone mineral density (BMD) and bone fractures in patients with moderate-to-severe COPD in the TOwards a Revolution in COPD Health (TORCH) study.
  
  
  METHODS
  A randomized, double-blind, parallel-group, placebo-controlled study conducted at 88 US centers involving 658 patients (a subset of 6,184 international subjects in TORCH). Therapy with placebo, SAL (50 microg), FP (500 microg), or SFC (SAL 50 microg/FP 500 microg) twice daily was administered for 3 years. Baseline and yearly measurements of BMD at the hip and lumbar spine were performed. The incidence of traumatic and nontraumatic bone fractures was recorded.
  
  
  RESULTS
  At baseline, 18% of men and 30% of women had osteoporosis, and 42% of men and 41% of women had osteopenia based on BMD assessments. Forty-three percent of subjects completed all testing. The changes in BMD at the hip and lumbar spine over 3 years were small. No significant differences were observed between treatment arms (adjusted mean percent change from baseline at hip was -3.1% for placebo, -1.7% for SAL, -2.9% for FP, and -3.2% for SFC therapy, respectively; while, the corresponding changes for the lumbar spine were 0, 1.5%, -0.3%, and -0.3% for placebo, respectively, SAL, FP, and SFC therapy). The incidence of fractures was low and was similar for all treatments (5.1% to 6.3%).
  
  
  CONCLUSIONS
  Osteoporosis is highly prevalent in patients with COPD, irrespective of gender. In the TORCH study, no significant effect on BMD was detected for ICS therapy compared with placebo.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NTC00268216.
authors: Pulmonary Research Institute of Southeast Michigan, Livonia, MI. Electronic address: garytferguson@msn.com.
authors: Gary T
authors: GT
authors: Ferguson
authors: Department of Medicine, University Hospital Aintree, Liverpool, UK.
authors: Peter M A
authors: PMA
authors: Calverley
authors: Respiratory Medicines Centre, GlaxoSmithKline, Middlesex, UK.
authors: Julie A
authors: JA
authors: Anderson
authors: Woolcock Institute of Medical Research, Camperdown, NSW, Australia.
authors: Christine R
authors: CR
authors: Jenkins
authors: Division of Cardiac and Vascular Science, St. George's, University of London, London, UK.
authors: Paul W
authors: PW
authors: Jones
authors: Respiratory Medicines Centre, GlaxoSmithKline, Middlesex, UK.
authors: Lisa R
authors: LR
authors: Willits
authors: Respiratory Medicines Centre, GlaxoSmithKline, Triangle Park, NC.
authors: Julie C
authors: JC
authors: Yates
authors: Department of Cardiology and Respiratory Medicine, Hvidovre Hospital, Hvidovre, Denmark; North West Lung Centre, Wythenshawe Hospital, Manchester, UK.
authors: Jørgen
authors: J
authors: Vestbo
authors: Pulmonary and Critical Care Division, Caritas St. Elizabeth's Medical Center, Tufts University School of Medicine, Boston, MA.
authors: Bartolome
authors: B
authors: Celli
mesh_terms: D000368:Aged; D000420:Albuterol / Q000009:adverse effects / Q000031:analogs & derivatives / Q000494:pharmacology / Q000627:therapeutic use; D000730:Androstadienes / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D015519:Bone Density / Q000187:drug effects; D001851:Bone Diseases, Metabolic / Q000139:chemically induced / Q000150:complications / Q000453:epidemiology; D001993:Bronchodilator Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D018450:Disease Progression; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D000068298:Fluticasone; D000068297:Fluticasone-Salmeterol Drug Combination; D050723:Fractures, Bone / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000139:chemically induced / Q000150:complications / Q000453:epidemiology*; D015995:Prevalence; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications* / Q000188:drug therapy*; D012307:Risk Factors; D000068299:Salmeterol Xinafoate; D016896:Treatment Outcome; D014481:United States
chemical_list: D000730:Androstadienes; D001993:Bronchodilator Agents; D004338:Drug Combinations; D000068297:Fluticasone-Salmeterol Drug Combination; D000068299:Salmeterol Xinafoate; D000068298:Fluticasone; D000420:Albuterol