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COMPLETEDPhase 2NCT00004488

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

OBJECTIVES: I. Determine the efficacy of alendronate sodium in treating osteopenia (generalized bone density and focal bone lesions) in patients with Gaucher's disease.

Lead sponsor: Children's Hospital Medical Center, Cincinnati•2 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Children's Hospital Medical Center, Cincinnati

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

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 25, 2015Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment82

Start dateOct 1998

Last updatedMar 25, 2015

Condition

Gaucher's Disease Osteopenia

Locations shown

Children's Hospital Medical Center - Cincinnati

Cincinnati, Ohio

Wright State University School of Medicine

Dayton, Ohio

Shaare Zedek Medical Center

Jerusalem

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 25, 2015Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions