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Bone mineral density in patients with chronic obstructive pulmonary disease treated with budesonide Turbuhaler®

¹ Dept of Orthopaedics, Malmö University Hospital, Malmö, Sweden. ² Dept of Respiratory Diseases, Ghent University Hospital, Ghent, Belgium. ³ Dept of Respiratory Medicine, University Hospital, Lund, Sweden. ⁴ Dept of Medicine, University Central Hospital, Helsinki, Finland. ⁵ Division of Respiratory Disease, University Hospital, Groningen, the Netherlands. ⁶ Respiratory Division, Imperial College School of Medicine, Hammersmith Hospital, London, UK. ⁷ AstraZeneca, Lund, Sweden

CORRESPONDENCE: O. Johnell, Dept of Orthopaedics, UMAS, S-205 02 Malmö, Sweden. Fax: 46 40336227. E-mail: olof.Johnell@orto.mas.lu.se

Keywords: bone mineral density, budesonide, chronic obstructive pulmonary disease, drug safety, fractures, inhaled steroids

Received: August 28, 2001
Accepted December 27, 2001

This study was supported by AstraZeneca Research and Development Lund, Lund, Sweden.

There is a need for studying the effects of long-term inhaled corticosteroid therapy on bone mineral density (BMD) and vertebral fracture rates in patients with mild chronic obstructive pulmonary disease (COPD).

Patients (n=912, mean age 52 yrs) with mild COPD (mean forced expiratory volume in one second (FEV₁) 77% of predicted; mean FEV₁/slow vital capacity ratio 62%) were randomized to receive budesonide 400 µg, or placebo twice daily via Turbuhaler®. BMD was measured at the L2–L4 vertebrae and the femoral neck, trochanter and Ward's triangle by dual-energy X-ray absorptiometry at baseline and after 6, 12, 24 and 36 months (n=161). Radiographs of the thoracic and lumbar spine were obtained at the beginning and end of treatment (n=653).

Previous fractures were present at baseline in 43 budesonide-treated patients (13.4%) and 38 placebo-treated patients (11.5%). New fractures occurred in five budesonide-treated patients, compared with three in the placebo group (p=0.50). There were no significant changes in BMD at any site in budesonide-treated patients, compared with the placebo group, during the course of the study. Budesonide treatment was associated with a slight but statistically significant decrease in the area under the concentration-time curve for serum osteocalcin.

In the present study, involving a large group of patients with chronic obstructive pulmonary disease, long-term treatment with budesonide 800 µg·day^–1 via Turbuhaler® had no clinically significant effects on bone mineral density or fracture rates.

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