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Alendronate improved BMD in young patients with cystic fibrosis
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Researchers in Italy suggest that an oral bisphosphonate indicated to curb bone loss improved bone mineral density among patients once other treatment methods had failed to do so.
They conducted a multicenter trial in two phases to investigate the treatment of low BMD in 171 children, adolescents and young adults aged 5 to 30 years (mean age, 13.8 years) with cystic fibrosis and low BMD from 10 cystic fibrosis regional centers.
According to researchers, the first phase was an open-label, 12-month observational study that examined the effects of calcium intake plus calcifediol. The administration of calcium and calcifediol increased bone mineral apparent density by 5% or more in 43 patients (25%), according to data.
The second phase was a 12-month, double blind, randomized, placebo-controlled, parallel group study on the efficacy and safety of oral alendronate (Fosamax, Merck) administered to patients with a BMD that did not increase by 5% or more by the end of the observational phase. Patients (n=128) were randomly assigned to alendronate or placebo.
According to data, BMD increased by 16.3% in the alendronate group (n=65) compared with 3.1% in the placebo group (n=63; P=.0010). Furthermore, 19 of 57 patients (33.3%) receiving alendronate demonstrated a normal-for-age bone mineral apparent density z score.
Adverse events in the observational phase included moderate episodes of hypercalciuria (n=5). Of those included in the randomized portion of the study, only one patient administered alendronate displayed a mild fever compared with none in the placebo group.
In an accompanying comment, Carole Le Henaff, PhD,Frédéric Velard, PhD, and Jacky Jacquot, PhD, all from SFR CAP-Santé, University Reims Champagne Ardenne, France, wrote that the study provides convincing evidence that the bisphosphonate alendronate is effective, well tolerated and safe for young patients with cystic fibrosis.
“Early recognition and treatment are the most effective strategies for sustaining bone health to help maintain quality of life in young patients with cystic fibrosis,” they wrote.
For more information:
Bianchi ML. Lancet. 2013; doi: 10.1016/S2213-2600(13)70064-X.
Le Henaff C. Lancet. 2013; doi: 10.1016/S2213-2600(13)70096-1.
Disclosure: The researchers report no relevant financial disclosures.