Gary T Ferguson1, Peter M A Calverley2, Julie A Anderson3, Christine R Jenkins4, Paul W Jones5, Lisa R Willits3, Julie C Yates6, Jørgen Vestbo7, Bartolome Celli8. 1. Pulmonary Research Institute of Southeast Michigan, Livonia, MI. Electronic address: garytferguson@msn.com. 2. Department of Medicine, University Hospital Aintree, Liverpool, UK. 3. Respiratory Medicines Centre, GlaxoSmithKline, Middlesex, UK. 4. Woolcock Institute of Medical Research, Camperdown, NSW, Australia. 5. Division of Cardiac and Vascular Science, St. George's, University of London, London, UK. 6. Respiratory Medicines Centre, GlaxoSmithKline, Triangle Park, NC. 7. Department of Cardiology and Respiratory Medicine, Hvidovre Hospital, Hvidovre, Denmark; North West Lung Centre, Wythenshawe Hospital, Manchester, UK. 8. Pulmonary and Critical Care Division, Caritas St. Elizabeth's Medical Center, Tufts University School of Medicine, Boston, MA.
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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NTC00268216.
RCT Entities:
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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NTC00268216.
Authors: E M Dennison; D K Dhanwal; S O Shaheen; R Azagra; I Reading; K A Jameson; A A Sayer; C Cooper Journal: Arch Osteoporos Date: 2013-01-15 Impact factor: 2.617
Authors: Caterina Trevisan; A Vianello; N Veronese; S Carraro; S Pizzato; P Lucato; G Girotti; C Rinaldo; A Coin; E Manzato; G Sergi Journal: Lung Date: 2016-10-03 Impact factor: 2.584