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Completed

NCT Number: NCT01439139

Bone UltraSonic Scanner (BUSS): Validation Study

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

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteopenia

Age range

50 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Catholic Health System Affiliates & Sister's of Charity Hospital

Buffalo, New York, 14220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Artann Laboratories

Industry

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Portable Bone Ultrasonometer for Osteoporosis Assessment

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 23, 2011
Registry last updated
Mar 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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