Bone mineral density in patients with chronic obstructive pulmonary disease treated with budesonide Turbuhaler.
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 microg, 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 microg x day(-1) via Turbuhaler had no clinically significant effects on bone mineral density or fracture rates.
Johnell
O
O
Dept of Orthopaedics, Malmö University Hospital, Sweden. olof.Johnell@orto.mas.lu.se
Pauwels
R
R
Löfdahl
C G
CG
Laitinen
L A
LA
Postma
D S
DS
Pride
N B
NB
Ohlsson
S V
SV
D000280:Administration, Inhalation; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D015519:Bone Density / Q000187:drug effects*; D019819:Budesonide / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015675:Osteocalcin / Q000097:blood; D010024:Osteoporosis / Q000000981:diagnostic imaging / Q000453:epidemiology; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*; D011859:Radiography; D012307:Risk Factors; D016103:Spinal Fractures / Q000000981:diagnostic imaging / Q000453:epidemiology
D000893:Anti-Inflammatory Agents; D015675:Osteocalcin; D019819:Budesonide