OsteoporosisNCT01978834
Age Dependend Diagnostic Thresholds for Osteoporosis Bindex Ultrasonometer
An observational study of Osteoporosis, run by Bone Index Finland Ltd at 1 site in United States.
Trial summary
This study is designed for clinical validation of the novel ultrasound device (Bindex®, Bone Index Finland Ltd.). In a preliminary study technique has been validated in Finnish elderly woman population with 285 healthy and 56 osteoporotic subjects (n = 341 in total). Read more about this study
- Who is it for?
- Ages 50 to 89 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- How many people
- 560 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Oct 2014
- How long will I take part?
- 1 Day
- 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 89 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female (American-Caucasian)
Who may be able to join
- Female sex
- Age 50 to 89 years
Who cannot join
- Those who have opted out of being contacted for research on their general Park Nicollet clinic consent will not be recruited by mail
- Inability to sign consent form due to cognitive impairment. Those with dementia (ICD-9 diagnosis codes 331.0, 294.1, 294.10, 294.11, or 294.8) will excluded from mailed recruitment
- Measurement of hip BMD is not feasible (for example, those who have had bilateral hip replacement surgeries or who cannot have central DXA because of their body weight)
- Open leg or arm wounds at sites where ultrasound measurements are supposed to be taken, precluding such measurements
Trial locations and contacts
1 site in 1 country.
United States1 site
Park Nicollet Institute
Minneapolis, Minnesota, 55416
About this study
This study is designed for clinical validation of the novel ultrasound device (Bindex®, Bone Index Finland Ltd.). In a preliminary study technique has been validated in Finnish elderly woman population with 285 healthy and 56 osteoporotic subjects (n = 341 in total). Significant and good correlation was observed between Density Index (DI) determined with Bindex and femoral bone mineral density determined with DXA (r = 0.65 - 0.70). In addition, with determination of 90% sensitivity and specificity thresholds, significant number (65-75%) of patients could be diagnosed without additional verification with DXA.
First, the thresholds for DI will be determined by measuring 70 osteoporotic and 70 healthy patients (n = 140) with Bindex and DXA within four decades of age; age 50 to 59 years, age 60 to 69 years, age 70 to 79 years, and age 80 to 89 years. The feasibility of DI for diagnostics of osteoporosis and evaluation of bone mineral density (BMD) will be assessed. The thresholds for the BMD estimate obtained with DI will be determined for osteoporotic and non-osteoporotic patients. For fracture risk assessment, DI measurements are used to predict the outcome of currently available fracture risk assessment tools.
- To investigate optimal configuration of ultrasound parameters and patient characteristics for prediction of proximal femur and lumbar spine BMD for women in each four decades of age; 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.
- To develop national diagnostic thresholds for DI in prediction of osteoporosis status with a reference female population (American-Caucasian) in each four decades of age; 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.
Read the detailed description
Data will be stored by Park Nicollet Institute. Only data listed below will be given to the research team at Bindex for analyses.
The data for determination of diagnostic threshold for DI in North American population will be analyzed by Bone Index Finland. The data will include following parameters:
- Age in years
- Weight
- Height
- Cortical thickness values at each location
- Density Index values
- Raw data on ultrasound signals.
- DXA measurement data
- Identification code (Uniquely created identification code given to a subject, does not carry any information on subject but enables tracing if needed.)
- Data from Appendix A, excluding patient name and medical record number
Risk factors will be collected in a separate questionnaire (Appendix A).
- Name
- Medical Record Number
- Weight (kg)
- Height (cm)
- Chair Stand test Can do easily; can do only with difficulty; cannot do Risk Factors:
- Previous fracture (Skeletal site, age at which fracture occured)
- Parent fractured hip (Yes, No)
- Current smoking (Yes, No)
- Glucocorticoid Use (Yes, No)
- Rheumatoid arthritis (Yes, No)
- Alcohol 3 or more units per day (Yes, No)
- Osteoporosis medication, type (e.g. alendronate, bisphosphonates), start- and end-date (Within the past five years)
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, diagnosis, ultrasound
- Medical subject headings
- Osteoporosis, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Thresholds for Bindex in Osteoporosis Diagnostics
Diagnostics thresholds for DI parameter for Osteoporosis within four decades of age; age 50 to 59 years, age 60 to 69 years, age 70 to 79 years, and age 80 to 89 years.
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 posted8 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2014
- Study completionOct 2014
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 560 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bone Index Finland Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- HealthPartners Institute
- Responsible party
- Sponsor
- Investigators
- John T Schousboe, MD, PhD, Principal investigator, HealthPartners InstituteJanne P Karjalainen, PhD, Study director, Bone Index Finland LtdOssi Riekkinen, PhD, Study director, Bone Index Finland Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978834
- Sponsor's protocol ID
- Bind02
- Other IDs
- BoneIndex02
- Status last verified
- Jan 2015
- First submitted
- 28 Oct 2013
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age Dependend Diagnostic Thresholds for Osteoporosis Bindex Ultrasonometer
- ClinicalTrials.gov ID
- NCT01978834
- Acronym / sponsor ID
- Bind02
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, diagnosis, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Bone Index Finland LtdIndustry (pharma, biotech, devices)
- Collaborators
- HealthPartners Institute
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 8 Nov 2013 (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.
This study is designed for clinical validation of the novel ultrasound device (Bindex®, Bone Index Finland Ltd.). In a preliminary study technique has been validated in Finnish elderly woman population with 285 healthy and 56 osteoporotic subjects (n = 341 in total). Significant and good correlation was observed between Density Index (DI) determined with Bindex and femoral bone mineral density determined with DXA (r = 0.65 - 0.70). In addition, with determination of 90% sensitivity and specificity thresholds, significant number (65-75%) of patients could be diagnosed without additional verification with DXA.
First, the thresholds for DI will be determined by measuring 70 osteoporotic and 70 healthy patients (n = 140) with Bindex and DXA within four decades of age; age 50 to 59 years, age 60 to 69 years, age 70 to 79 years, and age 80 to 89 years. The feasibility of DI for diagnostics of osteoporosis and evaluation of bone mineral density (BMD) will be assessed. The thresholds for the BMD estimate obtained with DI will be determined for osteoporotic and non-osteoporotic patients. For fracture risk assessment, DI measurements are used to predict the outcome of currently available fracture risk assessment tools.
- To investigate optimal configuration of ultrasound parameters and patient characteristics for prediction of proximal femur and lumbar spine BMD for women in each four decades of age; 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.
- To develop national diagnostic thresholds for DI in prediction of osteoporosis status with a reference female population (American-Caucasian) in each four decades of age; 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.
Detailed description
Data will be stored by Park Nicollet Institute. Only data listed below will be given to the research team at Bindex for analyses.
The data for determination of diagnostic threshold for DI in North American population will be analyzed by Bone Index Finland. The data will include following parameters:
- Age in years
- Weight
- Height
- Cortical thickness values at each location
- Density Index values
- Raw data on ultrasound signals.
- DXA measurement data
- Identification code (Uniquely created identification code given to a subject, does not carry any information on subject but enables tracing if needed.)
- Data from Appendix A, excluding patient name and medical record number
Risk factors will be collected in a separate questionnaire (Appendix A).
- Name
- Medical Record Number
- Weight (kg)
- Height (cm)
- Chair Stand test Can do easily; can do only with difficulty; cannot do Risk Factors:
- Previous fracture (Skeletal site, age at which fracture occured)
- Parent fractured hip (Yes, No)
- Current smoking (Yes, No)
- Glucocorticoid Use (Yes, No)
- Rheumatoid arthritis (Yes, No)
- Alcohol 3 or more units per day (Yes, No)
- Osteoporosis medication, type (e.g. alendronate, bisphosphonates), start- and end-date (Within the past five years)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 50 to 89 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female (American-Caucasian)
Key inclusion criteria (2 listed)
- Female sex
- Age 50 to 89 years
Key exclusion criteria (4 listed)
- Those who have opted out of being contacted for research on their general Park Nicollet clinic consent will not be recruited by mail
- Inability to sign consent form due to cognitive impairment. Those with dementia (ICD-9 diagnosis codes 331.0, 294.1, 294.10, 294.11, or 294.8) will excluded from mailed recruitment
- Measurement of hip BMD is not feasible (for example, those who have had bilateral hip replacement surgeries or who cannot have central DXA because of their body weight)
- Open leg or arm wounds at sites where ultrasound measurements are supposed to be taken, precluding such measurements
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
Thresholds for Bindex in Osteoporosis Diagnostics
Time frame: 1 year
Diagnostics thresholds for DI parameter for Osteoporosis within four decades of age; age 50 to 59 years, age 60 to 69 years, age 70 to 79 years, and age 80 to 89 years.
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 29 Jan 2015.
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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.
John T Schousboe, MD, PhD principal investigator
HealthPartners Institute
Janne P Karjalainen, PhD study director
Bone Index Finland Ltd
Ossi Riekkinen, PhD study director
Bone Index Finland Ltd
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, run by Bone Index Finland Ltd 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 4 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 29 Jan 2015. 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?
Thresholds for Bindex in Osteoporosis Diagnostics (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 29 Jan 2015.