Bone UltraSonic Scanner (BUSS): Validation Study
This study has been completed.
Information provided by (Responsible Party):
First received: September 21, 2011
Last updated: March 27, 2014
Last verified: March 2014
The aim of clinical study is to assess effectiveness of Bone UltraSonic Scanner (BUSS) versus densitometry (DXA) in osteoporosis detection.
||Observational Model: Case-Only
Time Perspective: Cross-Sectional
||Portable Bone Ultrasonometer for Osteoporosis Assessment
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2013 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||50 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Age 50-90 years
- Any race or ethnicity
- DXA spine and hip exam within one year
- 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:
- 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
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
|Catholic Health System Affiliates & Sister's of Charity Hospital
|Buffalo, New York, United States, 14220 |
||Armen Sarvazyan, Ph.D., D.Sc.
||Artann Laboratories, Inc
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 21, 2011
||March 27, 2014
||United States: Institutional Review Board
Keywords provided by Artann Laboratories:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2014
Bone Diseases, Metabolic