PT  - JOURNAL ARTICLE
AU  - Johnell, O.
AU  - Pauwels, R.
AU  - Löfdahl, C-G.
AU  - Laitinen, L.A.
AU  - Postma, D.S.
AU  - Pride, N.B.
AU  - Ohlsson, S.V.
TI  - Bone mineral density in patients with chronic obstructive pulmonary disease treated with budesonide Turbuhaler®
AID  - 10.1183/09031936.02.00276602
DP  - 2002 Jun 01
TA  - European Respiratory Journal
PG  - 1058--1063
VI  - 19
IP  - 6
4099  - http://erj.ersjournals.com/content/19/6/1058.short
4100  - http://erj.ersjournals.com/content/19/6/1058.full
SO  - Eur Respir J2002 Jun 01; 19
AB  - 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. This study was supported by AstraZeneca Research and Development Lund, Lund, Sweden.