NCT01439139

Brief Summary

The aim of clinical study is to assess effectiveness of Bone UltraSonic Scanner (BUSS) versus densitometry (DXA) in osteoporosis detection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2011

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

September 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

March 28, 2014

Status Verified

March 1, 2014

Enrollment Period

1.7 years

First QC Date

September 21, 2011

Last Update Submit

March 27, 2014

Conditions

OsteoporosisOsteopenia

Keywords

OsteoporosisultrasoundsonometerDXA

Outcome Measures

Primary Outcomes (1)

  • BUSS data will be able to discriminate between postmenopausal women with osteoporosis compared with no osteoporosis defined by DXA measurements.

    1 year

Eligibility Criteria

Age50 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Postmenopausal women

You may qualify if:

  • Postmenopausal
  • Age 50-90 years
  • Any race or ethnicity
  • DXA spine and hip exam within one year

You may not qualify if:

  • Open wounds or rashes on the testing area
  • Active skin infection
  • Recent tibia surgery
  • Abnormal tibia anatomy
  • Body Mass Index \> 34.9 kg/m2
  • Current or previous tibial fracture on side of testing
  • Stroke or 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:
  • Bisphosphonates
  • Calcitonin
  • Estrogens or selective estrogen receptor modulator (SERM)
  • Therapeutic doses of fluoride (\> 2mg/day)
  • Teriparatide used currently or within past 3 months
  • Drugs under research protocols, and
  • Unstudied or unapproved drugs
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic Health System Affiliates & Sister's of Charity Hospital

Buffalo, New York, 14220, United States

Location

MeSH Terms

Conditions

OsteoporosisBone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Armen Sarvazyan, Ph.D., D.Sc.

    Artann Laboratories, Inc

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

September 21, 2011

First Posted

September 23, 2011

Study Start

September 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

March 28, 2014

Record last verified: 2014-03

Locations

US(1)