Phase II Randomized Study of Alendronate Sodium for Osteopenia in Patients With Gaucher's Disease
NCT ID: NCT00004488
Last Updated: 2015-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
82 participants
INTERVENTIONAL
1998-10-31
2002-09-30
Brief Summary
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I. Determine the efficacy of alendronate sodium in treating osteopenia (generalized bone density and focal bone lesions) in patients with Gaucher's disease.
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Detailed Description
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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
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
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alendronate sodium
calcium carbonate
cholecalciferol
Eligibility Criteria
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Inclusion 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
18 Years
50 Years
ALL
No
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Principal Investigators
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Richard J. Wenstrup
Role: STUDY_CHAIR
Children's Hospital Medical Center, Cincinnati
Locations
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Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States
Wright State University School of Medicine
Dayton, Ohio, United States
Shaare Zedek Medical Center
Jerusalem, , Israel
Countries
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Other Identifiers
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CHMC-C-FDR001537
Identifier Type: -
Identifier Source: secondary_id
CHMC-C-498
Identifier Type: -
Identifier Source: secondary_id
199/14269
Identifier Type: -
Identifier Source: org_study_id
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