title: Efficacy of alendronate in adults with cystic fibrosis with low bone density.
abstract: As adults with cystic fibrosis (CF) have enjoyed incremental increases in longevity over the last few decades, they have also been suffering 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 with placebo (n = 24) for 1 year in 48 patients to improve bone mineral density at the spine as the primary endpoint. All patients received 800 IU of cholecalciferol and 1,000 mg of calcium carbonate. Both groups were similar in age, sex, CF 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 versus placebo, which lost (mean +/- SD) 1.8 +/- 4.0% and 0.7 +/- 4.7%, in spine and femur bone density, respectively (p < or = 0.001 for the spine; p = 0.003 for the femur). Urine N-telopeptide, a bone resorption marker, levels declined in the treatment group more than in the control group (p = 0.002), consistent with the known antiresorptive 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 CF.
authors.affiliation: Division of Pulmonary Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA. aris@med.unc.edu
authors.forename: Robert M
authors.initials: RM
authors.lastname: Aris
authors.forename: Gayle E
authors.initials: GE
authors.lastname: Lester
authors.forename: Melissa
authors.initials: M
authors.lastname: Caminiti
authors.forename: A Denene
authors.initials: AD
authors.lastname: Blackwood
authors.forename: Margaret
authors.initials: M
authors.lastname: Hensler
authors.forename: Robert K
authors.initials: RK
authors.lastname: Lark
authors.forename: Travis M
authors.initials: TM
authors.lastname: Hecker
authors.forename: Jordan B
authors.initials: JB
authors.lastname: Renner
authors.forename: Ursula
authors.initials: U
authors.lastname: Guillen
authors.forename: Sue A
authors.initials: SA
authors.lastname: Brown
authors.forename: Isabel P
authors.initials: IP
authors.lastname: Neuringer
authors.forename: Worakij
authors.initials: W
authors.lastname: Chalermskulrat
authors.forename: David A
authors.initials: DA
authors.lastname: Ontjes
mesh_terms: D000284:Administration, Oral; D000328:Adult; D019386:Alendronate / Q000627:therapeutic use*; D000704:Analysis of Variance; D015519:Bone Density / Q000187:drug effects; D001862:Bone Resorption / Q000517:prevention & control; D003550:Cystic Fibrosis / Q000150:complications* / Q000175:diagnosis; D003720:Densitometry; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D010024:Osteoporosis / Q000150:complications* / Q000188:drug therapy*; D011336:Probability; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D019386:Alendronate