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Phase II Randomized Study of Alendronate Sodium for Osteopenia in Patients With Gaucher's Disease

Osteopenia Clinical Trial

Clinical Trial Summary

OBJECTIVES:

I. Determine the efficacy of alendronate sodium in treating osteopenia (generalized bone density and focal bone lesions) in patients with Gaucher's disease.

Clinical Trial Description

PROTOCOL OUTLINE:

This is a randomized, double blind, placebo controlled study.

All patients receive oral calcium carbonate and cholecalciferol daily. Patients are randomized to receive oral alendronate sodium or placebo daily for 24 months.

Patients are followed every 6 months for 2 years.

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00004488
Study type Interventional
Source FDA Office of Orphan Products Development
Contact
Status Completed
Phase Phase 2
Start date October 1998
Completion date September 2002
View Details
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