Phase II Randomized Study of Alendronate Sodium for Osteopenia in Patients With Gaucher's Disease
I. Determine the efficacy of alendronate sodium in treating osteopenia (generalized bone density and focal bone lesions) in patients with Gaucher's disease.
|Gaucher's Disease Osteopenia||Drug: alendronate sodium Drug: calcium carbonate Drug: cholecalciferol||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Study Start Date:||October 1998|
|Estimated Study Completion Date:||September 2002|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004488
|United States, Ohio|
|Children's Hospital Medical Center - Cincinnati|
|Cincinnati, Ohio, United States, 45229-3039|
|Wright State University School of Medicine|
|Dayton, Ohio, United States, 45401|
|Shaare Zedek Medical Center|
|Jerusalem, Israel, 91031|
|Study Chair:||Richard J. Wenstrup||Children's Hospital Medical Center, Cincinnati|