Treatment of Low Bone Density in Cystic Fibrosis.

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Auxologico Italiano
• Collaborator: Fondazione Telethon
• Treatments: Alendronate

Criteria

Inclusion Criteria:

• age 2-30 years

• clinically stable condition

• regular menses in females

• low Bone Mineral Apparent Density for age (defined as BMAD Z-score ≤-2.0 if age ≤18 years or ≤-2.5 if age >18 years).

Exclusion Criteria:

• two or more episodes of hypercalcemia and/or hypercalciuria

• contraindications to 25-OH vitamin D or alendronate treatment

• recent transplantation

• other diseases or medications (glucocorticoids excepted) associated with bone loss.