Bone UltraSonic Scanner (BUSS): Validation Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Artann Laboratories
ClinicalTrials.gov Identifier:
NCT01439139
First received: September 21, 2011
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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


Condition
Osteoporosis
Osteopenia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Portable Bone Ultrasonometer for Osteoporosis Assessment

Resource links provided by NLM:


Further study details as provided by Artann Laboratories:

Primary Outcome Measures:
  • BUSS data will be able to discriminate between postmenopausal women with osteoporosis compared with no osteoporosis defined by DXA measurements. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: September 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Study will conduct measurements in a group of postmenopausal women and use their DXA examination data as a control. BUSS data will be able to discriminate between postmenopausal women with osteoporosis compared with no osteoporosis defined by DXA measurements.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Postmenopausal women

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Presence of metabolic bone disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439139

Locations
United States, New York
Catholic Health System Affiliates & Sister's of Charity Hospital
Buffalo, New York, United States, 14220
Sponsors and Collaborators
Artann Laboratories
Investigators
Study Chair: Armen Sarvazyan, Ph.D., D.Sc. Artann Laboratories, Inc
  More Information

No publications provided

Responsible Party: Artann Laboratories
ClinicalTrials.gov Identifier: NCT01439139     History of Changes
Other Study ID Numbers: BUSS-04, 2R44AG017400
Study First Received: September 21, 2011
Last Updated: March 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Artann Laboratories:
Osteoporosis
ultrasound
sonometer
DXA

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Osteoporosis
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 17, 2014