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


METHODS
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 FEV1 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.
Smith
B J
BJ
Department of Medicine, University of Adelaide, Australia. Brian.Smith@nwahs.sa.gov.au
Laslett
L L
LL
Pile
K D
KD
Phillips
P J
PJ
Phillipov
G
G
Evans
S M
SM
Esterman
A J
AJ
Berry
J G
JG
D015502:Absorptiometry, Photon; D000368:Aged; D019386:Alendronate / Q000627:therapeutic use*; D001249:Asthma / Q000150:complications* / Q000503:physiopathology; D015519:Bone Density; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D005541:Forced Expiratory Volume / Q000502:physiology; D006801:Humans; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications* / Q000503:physiopathology; D016896:Treatment Outcome
D050071:Bone Density Conservation Agents; D019386:Alendronate