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Chronic Respiratory Disease, Vol. 1, No. 3, 131-137 (2004)
DOI: 10.1191/1479972304cd025oa

Randomized controlled trial of alendronate in airways disease and low bone mineral density

B J Smith

Department of Medicine, University of Adelaide, Australia; Clinical Epidemiology and Health Outcomes Unit, The Queen Elizabeth Hospital, Australia; Respiratory Medicine, The Queen Elizabeth Hospital, Australia

L L Laslett

Clinical Epidemiology and Health Outcomes Unit, The Queen Elizabeth Hospital, Australia

K D Pile

Department of Medicine, University of Adelaide, Australia; Department of Rheumatology, The Queen Elizabeth Hospital, Australia

P J Phillips

G Phillipov

Department of Endocrinology, The Queen Elizabeth Hospital, Australia

S M Evans

Clinical Epidemiology and Health Outcomes Unit, The Queen Elizabeth Hospital, Australia

A J Esterman

Department of General Practice, Flinders University, Australia

J G Berry

Clinical Epidemiology and Health Outcomes Unit, The Queen Elizabeth Hospital, Australia

Background:Patients with airways disease have been demonstrated to be at risk of osteoporosis, and this is likely to be multifactorial. Our aim was to identify patients with low bone mineral density (BMD) using a screening program, and then evaluate the benefit of daily alendronate. Method:Subjects with hip or lumbar spine baseline T-scores <-2.5, or Z-score <-1.0 commenced on alendronate/calcium (10 mg/600 mg day) or placebo/calcium, in a double blind randomized controlled trial. BMD by dual emission X-ray absorptiometry (lumbar vertebrae 2-4, neck of femur, total femur) was repeated after 12 months, with adverse events recorded. Results: 145 subjects (74 male, 71 female, mean age 67, median FEV, 1.0 litres = 43% of predicted) were enrolled; 66 alendronate/calcium, 79 placebo/calcium with 24 and 26 withdrawals, respectively. Per protocol but not intention to treat analysis of covariance demonstrated statistically significant improvements in T and Z scores for lumbar spine bone mineral density (P = 0.035, P = 0.040), with no improvement demonstrated at the hip. Conclusions:Improvement in bone mineral density has been demonstrated at the lumbar spine, but not hip, by per protocol analysis, with daily alendronate, at 12 months.

Key Words: asthma • chronic obstructive airways disease • osteoporosis • treatment


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