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

Tracking Information

First Received Date ^ICMJE

October 18, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

October 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004488 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Gaucher's Disease
Osteopenia

Intervention ^ICMJE

Drug: alendronate sodium
Drug: calcium carbonate
Drug: cholecalciferol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of type 1 Gaucher's disease enzymatically proven to have acid beta glucosidase deficiency

Must have been on stable dose (8-60 U/kg/every 2 weeks) of alglucerase enzyme therapy (Cerezyme or Ceredase) for at least 24 months

Lumbar spine bone density below the mean for age, sex, and race

--Prior/Concurrent Therapy--

At least 6 months since prior medications that directly affect skeletal metabolism including, but not limited to, bisphosphonates, calcitonin, parathyroid hormone, or estrogen

--Patient Characteristics--

Renal: No chronic renal failure; No recurrent renal stones

Esophageal: No history of dysphagia; No frequent heartburn; No esophagitis requiring treatment

Other: No untreated hyperthyroidism or hypothyroidism; No concurrent hyperparathyroidism; No concurrent malignancy; No history of alcohol or drug abuse; Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States, Israel

Administrative Information

NCT ID ^ICMJE

NCT00004488

Responsible Party

Study ID Numbers ^ICMJE

199/14269, CHMC-C-FDR001537, CHMC-C-498

Study Sponsor ^ICMJE

FDA Office of Orphan Products Development

Collaborators ^ICMJE

Children's Hospital Medical Center, Cincinnati

Investigators ^ICMJE

Study Chair:

Richard J. Wenstrup

Children's Hospital Medical Center, Cincinnati

Information Provided By

FDA Office of Orphan Products Development

Verification Date

March 2000

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP