Phase II Randomized Study of Alendronate Sodium for Osteopenia in Patients With Gaucher's Disease
Recruitment status was Recruiting
I. Determine the efficacy of alendronate sodium in treating osteopenia (generalized bone density and focal bone lesions) in patients with Gaucher's disease.
Drug: alendronate sodium
Drug: calcium carbonate
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Study Start Date:||October 1998|
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.
|United States, Ohio|
|Children's Hospital Medical Center - Cincinnati||Recruiting|
|Cincinnati, Ohio, United States, 45229-3039|
|Contact: Richard J. Wenstrup 800-647-4805|
|Wright State University School of Medicine||Recruiting|
|Dayton, Ohio, United States, 45401|
|Contact: Shumei S. Guo 513-873-2933|
|Shaare Zedek Medical Center||Recruiting|
|Jerusalem, Israel, 91031|
|Contact: Ari Zimran 972-2-6555-111|
|Study Chair:||Richard J. Wenstrup||Children's Hospital Medical Center, Cincinnati|