Chest
Volume 136, Issue 6, December 2009, Pages 1456-1465
Journal home page for Chest

Original Research
COPD
Prevalence and Progression of Osteoporosis in Patients With COPD: Results From the Towards a Revolution in COPD Health Study

https://doi.org/10.1378/chest.08-3016Get rights and content

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 μg), FP (500 μg), or SFC (SAL 50 μg/FP 500 μg) 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

Section snippets

Design Overview, Setting, and Participants

Details of the TORCH study design and analyses have been published in detail elsewhere.13, 14 The authors of the TORCH study evaluated outpatients with moderate-to-severe COPD in 444 centers across 42 countries. The BMD study was conducted in 88 of these centers in the United States. Patients requiring OCS or long-term oxygen therapy at study entry were excluded. All patients gave written informed consent prior to participation in the study, which was approved by local ethical review boards,

Results

The bone density study population comprised 658 patients (47% of all US patients) [Fig 1]. All treatment groups were similar with respect to age, gender, FEV1, BMI, and the number of exacerbations treated with antibiotics and/or OCSs or requiring hospitalization in the prior year. Patient activity levels, as estimated by SGRQ activity score, and the number of patients receiving ICSs, OCSs, bisphosphonates, or other BMD medications (calcium, vitamin D, or hormone replacement therapy) recorded at

Discussion

The TORCH study is the first to prospectively investigate the long-term safety of therapy with an ICS in combination with an inhaled LABA and either component alone with respect to BMD in patients with COPD. There were three important findings in the study. First, the prevalence of osteoporosis and osteopenia in patients with COPD is very high, irrespective of gender. Second, no statistically or clinically significant differences in BMD or fractures were observed between placebo and any of the

Conclusions

We observed a high prevalence of osteopenia and osteoporosis in men and women with COPD. It is important to remain aware of these potentially treatable conditions. Although safety concerns remain paramount in the care of patients with COPD, the results of the TORCH study are reassuring as we did not detect that either SFC or its individual components had a significant effect on BMD compared with placebo over 3 years.

Acknowledgments

Author contributions: The TORCH Steering Committee, comprising six academics and three representatives of the sponsor, developed the design and concept, approved the statistical plan, had full access to and interpreted the data, wrote the article, and was responsible for decisions with regard to publication. Dr. Ferguson served as the primary author, reviewing all data, and wrote the article. Dr. Calverley developed the study protocol, was a study investigator, interpreted study data,

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Funding/Support: Supported by GlaxoSmithKline grant No. SCO30003.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/site/misc/reprints.xhtml).

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