NCT02067247

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

7 months

First QC Date

January 27, 2014

Last Update Submit

November 18, 2014

Conditions

Gaucher Disease Type 1

Outcome Measures

Primary Outcomes (1)

  • BMD measurements by DEXA and SOS

    6 months

Secondary Outcomes (1)

  • T-score and Z-score by DEXA and SOS

    6 months

Study Arms (1)

SOS forearm test

EXPERIMENTAL

BeamMed Speed-of-Sound bone strength test at forearm

Device: BeamMed Speed-of-Sound bone strength test at forearm

Interventions

BeamMed Speed-of-Sound bone strength test at forearmDEVICE

BeamMed Speed-of-Sound bone strength test at forearm in addition to the DEXA test

Also known as: OMNISENSE 7000S ULTRASOUND BONE SONOMETER
SOS forearm test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Minors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel, Israel

Location

Related Publications (1)

  • Baskin E, Dinur T, Lebel E, Tiomkin M, Elstein D, Zimran A. Comparison of Bone Mineral Density by Dual-Energy X-Ray Absorptiometry and Bone Strength by Speed-of-Sound Ultrasonography in Adults With Gaucher Disease. J Clin Densitom. 2016 Oct;19(4):465-470. doi: 10.1016/j.jocd.2015.12.002. Epub 2016 Jan 15.

    PMID: 26781431DERIVED

MeSH Terms

Conditions

Gaucher Disease

Condition Hierarchy (Ancestors)

SphingolipidosesLysosomal Storage Diseases, Nervous SystemBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLipidosesLipid Metabolism, Inborn ErrorsLysosomal Storage DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism Disorders

Study Officials

  • Ari Zimran, Prof.

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 27, 2014

First Posted

February 20, 2014

Study Start

February 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

IL(1)