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Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis

Cystic Fibrosis Clinical Trial

Clinical Trial Summary

OBJECTIVES: I. Determine the bioavailability and biologic effect of alendronate on bone metabolism in patients with cystic fibrosis.

II. Assess the safety and efficacy of this treatment regimen in improving osteoporosis in this patient population.

Clinical Trial Description

PROTOCOL OUTLINE: This is a randomized, double blind study. Patients will be stratified according to sex (male vs female) and osteoporosis disease severity (mild vs severe). Patients are randomized to one of two treatment arms.

Patients undergo bioavailability assessment to confirm the ability to absorb alendronate.

Arm I: Patients receive calcium and vitamin D supplements with a placebo daily for one month.

Arm II: Patients receive calcium and vitamin D supplements with oral alendronate daily for one month.

Treatment continues if differences are seen in bone mineral density between the treatment arms.

Patients are followed for biochemical response at week 6, 12, and 52. Bone mineral density is measured at 1 year and 2 years.

Completion date provided represents the completion date of the grant per OOPD records ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00004489
Study type Interventional
Source FDA Office of Orphan Products Development
Contact
Status Completed
Phase N/A
Start date October 1998
Completion date September 2002
View Details
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