OsteoporosisNCT01439139
Bone UltraSonic Scanner (BUSS): Validation Study
An observational study of Osteoporosis and Osteopenia, run by Artann Laboratories at 1 site in United States.
Trial summary
The aim of clinical study is to assess effectiveness of Bone UltraSonic Scanner (BUSS) versus densitometry (DXA) in osteoporosis detection. Read more about this study
- Who is it for?
- Ages 50 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteopenia
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Postmenopausal women
Who may be able to join
- Postmenopausal
- Age 50-90 years
- Any race or ethnicity
- DXA spine and hip exam within one year
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Catholic Health System Affiliates & Sister's of Charity Hospital
Buffalo, New York, 14220
About this study
Official title: Portable Bone Ultrasonometer for Osteoporosis Assessment
The aim of clinical study is to assess effectiveness of Bone UltraSonic Scanner (BUSS) versus densitometry (DXA) in osteoporosis detection.
Read the 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.
- Conditions
- Osteoporosis, Osteopenia
- Keywords
- Osteoporosis, ultrasound, sonometer, DXA
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What is being measured
The primary outcome is the main question the study is designed to answer.
BUSS data will be able to discriminate between postmenopausal women with osteoporosis compared with no osteoporosis defined by DXA measurements.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artann Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Armen Sarvazyan, Ph.D., D.Sc., Study chair, Artann Laboratories, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439139
- Sponsor's protocol ID
- BUSS-04
- Other IDs
- 2R44AG017400
- Status last verified
- Mar 2014
- First submitted
- 21 Sep 2011
- Last updated
- 28 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portable Bone Ultrasonometer for Osteoporosis Assessment
- ClinicalTrials.gov ID
- NCT01439139
- Acronym / sponsor ID
- BUSS-04
- Conditions
- Osteoporosis, Osteopenia
- Keywords
- Osteoporosis, ultrasound, sonometer, DXA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Artann LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Sep 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of clinical study is to assess effectiveness of Bone UltraSonic Scanner (BUSS) versus densitometry (DXA) in osteoporosis detection.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women
Key inclusion criteria (4 listed)
- Postmenopausal
- Age 50-90 years
- Any race or ethnicity
- DXA spine and hip exam within one year
Key exclusion criteria (16 listed)
- Open wounds or rashes on the testing area
- Active skin infection
- Recent tibia surgery
- Abnormal tibia anatomy
- Body Mass Index > 34.9 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BUSS data will be able to discriminate between postmenopausal women with osteoporosis compared with no osteoporosis defined by DXA measurements.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armen Sarvazyan, Ph.D., D.Sc. study chair
Artann Laboratories, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Osteopenia, run by Artann Laboratories at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BUSS data will be able to discriminate between postmenopausal women with osteoporosis compared with no osteoporosis defined by DXA measurements. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2014; AzTrials last refreshed its copy on 27 Oct 2026.