Overview

Treatment of Low Bone Density in Cystic Fibrosis.

Status:
Completed
Trial end date:
2007-07-01
Target enrollment:
Participant gender:
Summary
Cystic fibrosis (CF) -- an autosomal recessive genetic disease affecting about 60,000 individuals worldwide, including about 3,800 in Italy -- is often associated with low bone mineral mass. The current aggressive therapies have ensured a much longer survival of CF patients but this has led to a higher frequency of osteoporosis and bone fractures, a serious problem which not only affects quality of life, but also hinders further therapeutic measures. The aim of this study, conducted on a large group of children, adolescents and young adults with CF, has been the evaluation of bone mass changes after 1 year of a simple treatment with RDA-adjusted dietary calcium plus 25-OH vitamin D supplementation, and the feasibility and efficacy of alendronate treatment (for another year) in patients not responding to calcium + 25-OH vitamin D alone.
Phase:
Phase 3
Details
Lead Sponsor:
Istituto Auxologico Italiano
Collaborator:
Fondazione Telethon
Treatments:
Alendronate