NCT00004488

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Gaucher's Disease
• Osteopenia

Interventions

Type	Name	Description
DRUG	alendronate sodium
DRUG	calcium carbonate
DRUG	cholecalciferol

Timeline

• Start date: 1998-10-01
• Completion: 2002-09-01
• First posted: 1999-10-19
• Last updated: 2015-03-25

Locations

3 sites across 2 countries: United States, Israel