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
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: 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:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 19, 2014