Phase II Randomized Study of Alendronate Sodium for Osteopenia in Patients With Gaucher's Disease
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00004488 |
Recruitment Status :
Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
OBJECTIVES:
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 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 82 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Study Start Date : | October 1998 |
Study Completion Date : | September 2002 |


Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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 | |
Israel | |
Shaare Zedek Medical Center | |
Jerusalem, Israel, 91031 |
Study Chair: | Richard J. Wenstrup | Children's Hospital Medical Center, Cincinnati |
ClinicalTrials.gov Identifier: | NCT00004488 |
Other Study ID Numbers: |
199/14269 CHMC-C-FDR001537 CHMC-C-498 |
First Posted: | October 19, 1999 Key Record Dates |
Last Update Posted: | March 25, 2015 |
Last Verified: | March 2000 |
Gaucher's disease inborn errors of metabolism rare disease sphingolipidoses |
Bone Diseases, Metabolic Gaucher Disease Bone Diseases Musculoskeletal Diseases Metabolic Diseases Sphingolipidoses Lysosomal Storage Diseases, Nervous System Brain Diseases, Metabolic, Inborn Brain Diseases, Metabolic Brain Diseases Central Nervous System Diseases Nervous System Diseases Metabolism, Inborn Errors Genetic Diseases, Inborn Lipidoses |
Lipid Metabolism, Inborn Errors Lysosomal Storage Diseases Lipid Metabolism Disorders Cholecalciferol Vitamin D Alendronate Calcium Carbonate Calcium Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vitamins Micronutrients Bone Density Conservation Agents Antacids Molecular Mechanisms of Pharmacological Action |