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Comparison of BMD Measurement by DEXA to BeamMed Speed-of-Sound Measurement at Forearm in Patients With Gaucher 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. Identifier: NCT02067247
Recruitment Status : Completed
First Posted : February 20, 2014
Last Update Posted : November 19, 2014
Information provided by (Responsible Party):
Ari Zimran, Shaare Zedek Medical Center

Brief Summary:
The purpose of this study is to compare the accuracy and comparability and secondarily to assess the values achieved by measurement of the forearm BMD by DXA and SOS by BeamMed, relative to standard DXA evaluations at the FN and LS.

Condition or disease Intervention/treatment Phase
Gaucher Disease Type 1 Device: BeamMed Speed-of-Sound bone strength test at forearm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Comparison of BMD Measurements by Dual Energy X-Ray Absorptiometry and Multiple Sites to BeamMed Speed-of-Sound Measurements at the Forearm in Patients With Gaucher Disease
Study Start Date : February 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: SOS forearm test
BeamMed Speed-of-Sound bone strength test at forearm
Device: BeamMed Speed-of-Sound bone strength test at forearm
BeamMed Speed-of-Sound bone strength test at forearm in addition to the DEXA test

Primary Outcome Measures :
  1. BMD measurements by DEXA and SOS [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. T-score and Z-score by DEXA and SOS [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age: >18
  • Gaucher disease type 1
  • Able to undergo a DEXA test

Exclusion Criteria:

  • Minors

Information from the National Library of Medicine

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 identifier (NCT number): NCT02067247

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Shaare Zedek Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Shaare Zedek Medical Center
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Principal Investigator: Ari Zimran, Prof. Shaare Zedek Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ari Zimran, Prof., Shaare Zedek Medical Center Identifier: NCT02067247    
Other Study ID Numbers: DEXA-SOS
First Posted: February 20, 2014    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Gaucher Disease
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
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases
Lipid Metabolism Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors