Published ahead of print on October 16, 2003, doi:10.1164/rccm.200307-1049OC Am. J. Respir. Crit. Care Med., Volume 169, Number 1, January 2004, 77-82 A more recent version of this article appeared on January 1, 2004
Submitted on August 1, 2003 Efficacy of Alendronate in Cystic Fibrosis Adults with Low Bone DensityRobert M Aris1*,1 Pulmonary Medicine, The Cystic Fibrosis and Pulmonary Research Center, University of North Carolina, Chapel Hill, NC, USA, 2 Orthopedics, University of North Carolina, Chapel Hill, NC, USA, 3 Radiology, University of North Carolina, Chapel Hill, NC, USA, 4 University of North Carolina School of Medicine, Chapel Hill, NC, USA, 5 Endocrinology, The Cystic Fibrosis and Pulmonary Research Center, University of North Carolina, Chapel Hill, NC, USA * To whom correspondence should be addressed. E-mail: aris{at}med.unc.edu.
As adults with cystic fibrosis have enjoyed incremental increases in longevity over the last few decades, they have also been suffered from low bone density and its clinical manifestations, fractures and kyphosis. We conducted a placebo-controlled, randomized, double-blinded trial of alendronate (10 mg/day orally) (n=24) compared to placebo (n=24) for 1 year in 48 patients in order to improve bone mineral density at the spine as the primary endpoint. All patients received 800IU of cholecalciferol and 1000mg of calcium carbonate. Both groups were similar in age, gender, cystic fibrosis mutations, bone density T-scores, renal function, and body mass index at study onset. The alendronate treated patients gained (mean±SD) 4.9±3.0% and 2.8±3.2% bone density after 1 year vs. placebo, which lost (mean±SD) 1.8±4.0% and 0.7 ±4.7%, in spine and femur bone density respectively (p<0.001 for the spine; p=0.003 for the femur). Urine N-telopeptides levels, a bone resorption marker, declined in the treatment group more than in the controls (p=0.002) consistent with the known anti-resorptive effects of bisphosphonates. Alendronate was more effective than placebo in improving spine and femur bone mineral density and is a promising agent for the long-term prevention and management of bone disease in patients with cystic fibrosis. Key words: osteoporosis, cystic fibrosis, bisphosphonates, bone metabolism, alendronate
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