OsteoporosisBUSS03NCT01123421
Develop and Validate Ultrasonic Device for Osteoporotic Fracture Risk Assessment
An observational study of Osteoporosis and Fracture, run by Artann Laboratories at 1 site in United States.
Trial summary
Study to demonstrate that the Bone UltraSonic Scanner (BUSS) can aid in detection of osteoporosis and predict prevalent osteoporotic fractures. Measurements derived from the BUSS parameters will be able to discriminate between postmenopausal women with osteoporotic fractures when compared to matched controls without… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Osteoporosis, Fracture, Aging
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Feb 2012
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Both groups
Who may be able to join
- postmenopausal women with osteoporotic fracture at spine or wrist
- postmenopausal women no history of fracture at spine or wrist
Who cannot join
- women with a history of metabolic disease
- stroke
- tibia fracture or surgery
- BMI ≥ 35 kg/m2
- Teriparatide use currently or within the past 6 months,
- Any skin issues (open wounds or rashes, and/or skin infections) of the tibial area.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Portable Ultrasonometer for Osteoporosis Assessment: Retrospective Fracture Risk Validation Study, Version #1
Study to demonstrate that the Bone UltraSonic Scanner (BUSS) can aid in detection of osteoporosis and predict prevalent osteoporotic fractures. Measurements derived from the BUSS parameters will be able to discriminate between postmenopausal women with osteoporotic fractures when compared to matched controls without history of osteoporotic fracture.
Read the detailed description
One of several studies to develop and clinically validate a novel ultrasonographic device, BUSS, for the assessment of osteoporosis and fracture risk.
- Conditions
- Osteoporosis, Fracture, Aging
- Keywords
- osteoporosis, fracture risk, aging, tibia, sonometer, ultrasound, BMD, bone mineral density, DXA, 3D-HRpQT, waveform profiles
- Medical subject headings
- Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| With osteoporotic fracture | Approximately 100 postmenopausal women that have been enrolled in a population-based case-control study that have experienced a clinically-diagnosed fracture of thoracolumbar spine or distal forearm due to minimal or moderate trauma based on review on their inpatient and outpatient medical records will be enrolled. | |
| Without osteoporotic fracture | Approximately 100 control women will have no history of a prior spine, hip, or wrist fracture. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether BUSS testing is equivalent or superior to DXA for fracture risk assessment in postmenopausal women.
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 posted14 May 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2011
- Study completionFeb 2012
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-control
- Time perspective
- Retrospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artann Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA), Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Armen Sarvazyan, Ph.D., D.Sc., Principal investigator, Artann Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123421
- Sponsor's protocol ID
- BUSS03
- Other IDs
- 2R44AG017400
- Acronym
- BUSS03
- Status last verified
- Oct 2012
- First submitted
- 12 May 2010
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portable Ultrasonometer for Osteoporosis Assessment: Retrospective Fracture Risk Validation Study, Version #1
- ClinicalTrials.gov ID
- NCT01123421
- Acronym / sponsor ID
- BUSS03 / BUSS03
- Conditions
- Osteoporosis, Fracture, Aging
- Keywords
- osteoporosis, fracture risk, aging, tibia, sonometer, ultrasound, BMD, bone mineral density
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Artann LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA), Mayo Clinic
- Study start
- May 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 14 May 2010 (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.
Study to demonstrate that the Bone UltraSonic Scanner (BUSS) can aid in detection of osteoporosis and predict prevalent osteoporotic fractures. Measurements derived from the BUSS parameters will be able to discriminate between postmenopausal women with osteoporotic fractures when compared to matched controls without history of osteoporotic fracture.
Detailed description
One of several studies to develop and clinically validate a novel ultrasonographic device, BUSS, for the assessment of osteoporosis and fracture risk.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With osteoporotic fracture | – | –Approximately 100 postmenopausal women that have been enrolled in a population-based case-control study that have experienced a clinically-diagnosed fracture of thoracolumbar spine or distal forearm due to minimal or moderate trauma based on review on their inpatient and outpatient medical records will be enrolled. |
| Without osteoporotic fracture | – | –Approximately 100 control women will have no history of a prior spine, hip, or wrist fracture. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Both groups
Key inclusion criteria (2 listed)
- postmenopausal women with osteoporotic fracture at spine or wrist
- postmenopausal women no history of fracture at spine or wrist
Key exclusion criteria (6 listed)
- women with a history of metabolic disease
- stroke
- tibia fracture or surgery
- BMI ≥ 35 kg/m2
- Teriparatide use currently or within the past 6 months,
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
Determine whether BUSS testing is equivalent or superior to DXA for fracture risk assessment in postmenopausal women.
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 15 Oct 2012.
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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. principal investigator
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 Fracture, 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 2 inclusion and 6 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 15 Oct 2012. 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?
Determine whether BUSS testing is equivalent or superior to DXA for fracture risk assessment in postmenopausal women. (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 15 Oct 2012.