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

Phase 2

Completed

• Conditions: Gaucher's Disease; Osteopenia

• Registration Number: NCT00004488
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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

Study Timeline

• Study Start: 1998-10
• Study First Submitted: 1999-10-18
• Study First Submitted QC: 1999-10-18
• Study First Posted: 1999-10-19
• Status Verified: 2000-03
• Study Completion: 2002-09
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (3)

Wright State University School of Medicine; 🇺🇸 Dayton, Ohio, United States

Children's Hospital Medical Center - Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel