NCT01056432

Brief Summary

The aim of this clinical study using Bone UltraSonic Scanner (BUSS) is to obtain clinical data which will help to optimize the BUSS examination procedure and its diagnostic algorithms for assessment of bone conditions.

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 all trials

Timeline
Completed

Started Jan 2010

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

March 31, 2014

Status Verified

March 1, 2014

Enrollment Period

1 year

First QC Date

January 24, 2010

Last Update Submit

March 28, 2014

Conditions

Osteoporosis

Keywords

osteoporosis, bone fracture risk, bone ultrasonometry

Outcome Measures

Primary Outcomes (1)

  • To obtain clinical data which will help to optimize the BUSS examination procedure and its diagnostic algorithms for assessment of bone conditions.

    6 months

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study participants will consist of groups with no history of osteoporosis, established osteoporosis and may include documented history of fracture.

You may qualify if:

  • Any race or ethnical group DEXA examination scheduled within next two weeks or DEXA examination was completed within the last six months adn DEXA results are available

You may not qualify if:

  • Open wounds or rashes on the tibial testing area Active skin infection Recent tibia surgery Abnormal tibia Anatomy Current or previous tibial fracture Body Mass Index \>34.9 Hyperparathyroidism or hypoparathyroidism within 5 years Osteitis deformans Renal osteodystrophy Osteomalacia Stroke with total or partial paralysis with residual disability lasting more than 3 months Current or recent (within past 6 months) use of bone-active drugs Drugs under research protocols Chronic use of over the counter antacids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Smart Medical Center

Philadelphia, Pennsylvania, 19115, United States

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Armen Sarvazyan, Ph.D., D.Sc.

    Artann Laboratories

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2010

First Posted

January 26, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

March 31, 2014

Record last verified: 2014-03

Locations

US(1)