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Comparison of BMD Measurement by DEXA to BeamMed Speed-of-Sound Measurement at Forearm in Patients With Gaucher Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02067247
First Posted: February 20, 2014
Last Update Posted: November 19, 2014
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.
Information provided by (Responsible Party):
Ari Zimran, Shaare Zedek Medical Center
  Purpose
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 Intervention
Gaucher Disease Type 1 Device: BeamMed Speed-of-Sound bone strength test at forearm

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ari Zimran, Shaare Zedek Medical Center:

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

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

Enrollment: 100
Study Start Date: February 2014
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: OMNISENSE 7000S ULTRASOUND BONE SONOMETER

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Minors
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02067247


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ari Zimran, Prof., Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02067247     History of Changes
Other Study ID Numbers: DEXA-SOS
First Submitted: January 27, 2014
First Posted: February 20, 2014
Last Update Posted: November 19, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Gaucher Disease
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
Metabolic Diseases
Lipid Metabolism Disorders
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
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