Phase II Randomized Study of Alendronate Sodium for Osteopenia in Patients With Gaucher's Disease
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|ClinicalTrials.gov Identifier: NCT00004488|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
I. Determine the efficacy of alendronate sodium in treating osteopenia (generalized bone density and focal bone lesions) in patients with Gaucher's disease.
|Condition or disease||Intervention/treatment||Phase|
|Gaucher's Disease Osteopenia||Drug: alendronate sodium Drug: calcium carbonate Drug: cholecalciferol||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||82 participants|
|Intervention Model:||Single Group Assignment|
|Study Start Date :||October 1998|
|Estimated Study Completion Date :||September 2002|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|