Trial record 8 of 20 for:    Open Studies | "Gaucher Disease"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Shaare Zedek Medical Center
Sponsor:
Information provided by (Responsible Party):
Ari Zimran, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT02067247
First received: January 27, 2014
Last updated: February 18, 2014
Last verified: February 2014
  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: 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 Shaare Zedek Medical Center:

Primary Outcome Measures:
  • BMD measurements by DEXA and SOS [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • T-score and Z-score by DEXA and SOS [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2014
Estimated Study Completion Date: September 2014
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02067247

Contacts
Contact: Ari Zimran, Prof. 972-2-6555431 azimran@gmail.com
Contact: Liana Babchenko 972-508231966 babchenko@gmail.com

Locations
Israel
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel
Principal Investigator: Ari Zimran, Prof.         
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Ari Zimran, Prof. Shaare Zedek Medical Center
  More Information

No publications provided

Responsible Party: Ari Zimran, Prof., Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02067247     History of Changes
Other Study ID Numbers: DEXA-SOS
Study First Received: January 27, 2014
Last Updated: February 18, 2014
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on July 29, 2014