OsteoporosisNCT01935232
Bindex Ultrasonometer for Osteoporosis Diagnostics
An observational study of Osteoporosis, run by Bone Index Finland Ltd at 1 site in United States.
Trial summary
Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture risk. Among 200 million osteoporotic patients (Tarantino, Cannata et al. 2007) most are diagnosed only after a fracture. We expect with our aging population to see a significant increase in the prevalence of osteoporosis. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Dec 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: American-Caucasian female (n=500) American-Caucasian men (n=140)
Who may be able to join
- Postmenopausal women and men referred for bone density examination.
Who cannot join
- Patients unable to sign consent for participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Bindex Bone Ultrasonometer for Osteoporosis Diagnostics
Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture risk. Among 200 million osteoporotic patients (Tarantino, Cannata et al. 2007) most are diagnosed only after a fracture. We expect with our aging population to see a significant increase in the prevalence of osteoporosis. It is estimated that over 75% of osteoporotic patients are not diagnosed and do not receive treatment for their condition.
This research plan describes a study for clinical validation of the novel ultrasound device (Bindex®, Bone Index Finland Ltd.). In a preliminary study, the technique has been validated in a Finnish postmenopausal woman population of 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 neck 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.
Read more
For validation of the technique in US population, our study plan is presented for determination of diagnostic thresholds for osteoporosis. Taken together, DI with Bindex, lumbar spine and femoral bone BMD with DXA are obtained from 500 postmenopausal women and 140 men. The study will be carried out at the HealthEast Osteoporosis Care service in Woodbury, MN.
- To investigate the capability of DI for prediction of proximal femur and lumbar spine BMD;
- To develop national diagnostic thresholds for DI in prediction of osteoporosis status with a reference population (American-Caucasian) of 500 (if prevalence of osteoporosis is 20%) post-menopausal females (50-90 years);
- To investigate ability of Density Index + FRAX with BMI in fracture risk prediction;
- To investigate correlation between lumbar spine or proximal femur BMD and Density Index in 140 men at wide age range (20-90 years), 70 with osteoporosis and 70 with normal or low bone mass. Determine diagnostic thresholds for DI in men.
Read the detailed description
Quality
On-site training for the ultrasound device will be provided. Reproducibility shall be determined for each operator. After 100 patient have been measured, data shall be analysed, validated for value ranges and for consistency with other data fields in registry. Assessment of possible missing data fields. If measurement related, corrective and preventive actions shall be taken prior continuation of the study.
Data Registry
Data will be collected at the time of the bone density and ultrasound (DI) exams. Information collected will be entered into a database for statistical analysis. In addition to patient characteristics, 7 questions shall be presented to each patient to gather fracture risk related data (http://www.shef.ac.uk/FRAX):
- Previous fracture
- Parent fip fracture
- Current smoking
- Use of Glucocorticoids
- Rheumatoid arthritis
- Secondary osteoporosis
- Alcohol 3 or more units/day
Confidentiality
- Any of the data from this study will not be a part of permanent record (identifiable to the subject) that will be made available to physician, employer, supervisor, student, FDA, etc.
- Data will be kept in paper form indefinitely at HealthEast Osteoporosis Care. All research data is kept in locked cabinetry.
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, diagnostics, ultrasound
- Medical subject headings
- Osteoporosis
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 |
|---|---|---|
| Men | 140 Men | |
| Female | 500 Female |
What is being measured
The primary outcome is the main question the study is designed to answer.
Threshold values for DI to reach 90% sensitivity and specificity with the method in diagnostics of Osteoporosis.
Measured: 1 year
Secondary outcomes (1)
Amount subjects that can be diagnosed with the established thresholds for DI. Amount of subjects that would require additional examination to verify diagnosis.Correlation between BMD at neck, total hip and lumbar spine with DI.
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 posted5 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Institution not able to carry out research as of 2015
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
- 135 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bone Index Finland Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- HealthEast Care System
- Responsible party
- Sponsor
- Investigators
- Christine Simonelli, MD, Principal investigator, HealthEast Osteoporosis CareJanne P Karjalainen, PhD, Study director, Bone Index Finland LtdOssi Riekkinen, PhD, Study director, Bone Index Finland Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935232
- Sponsor's protocol ID
- Bind01
- Other IDs
- BoneIndex01
- Status last verified
- May 2017
- First submitted
- 21 Aug 2013
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Bindex Bone Ultrasonometer for Osteoporosis Diagnostics
- ClinicalTrials.gov ID
- NCT01935232
- Acronym / sponsor ID
- Bind01
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, diagnostics, ultrasound
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Institution not able to carry out research as of 2015
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Bone Index Finland LtdIndustry (pharma, biotech, devices)
- Collaborators
- HealthEast Care System
- Study start
- Aug 2013 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Sep 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.
Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture risk. Among 200 million osteoporotic patients (Tarantino, Cannata et al. 2007) most are diagnosed only after a fracture. We expect with our aging population to see a significant increase in the prevalence of osteoporosis. It is estimated that over 75% of osteoporotic patients are not diagnosed and do not receive treatment for their condition.
This research plan describes a study for clinical validation of the novel ultrasound device (Bindex®, Bone Index Finland Ltd.). In a preliminary study, the technique has been validated in a Finnish postmenopausal woman population of 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 neck 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.
For validation of the technique in US population, our study plan is presented for determination of diagnostic thresholds for osteoporosis. Taken together, DI with Bindex, lumbar spine and femoral bone BMD with DXA are obtained from 500 postmenopausal women and 140 men. The study will be carried out at the HealthEast Osteoporosis Care service in Woodbury, MN.
- To investigate the capability of DI for prediction of proximal femur and lumbar spine BMD;
- To develop national diagnostic thresholds for DI in prediction of osteoporosis status with a reference population (American-Caucasian) of 500 (if prevalence of osteoporosis is 20%) post-menopausal females (50-90 years);
- To investigate ability of Density Index + FRAX with BMI in fracture risk prediction;
- To investigate correlation between lumbar spine or proximal femur BMD and Density Index in 140 men at wide age range (20-90 years), 70 with osteoporosis and 70 with normal or low bone mass. Determine diagnostic thresholds for DI in men.
Detailed description
Quality
On-site training for the ultrasound device will be provided. Reproducibility shall be determined for each operator. After 100 patient have been measured, data shall be analysed, validated for value ranges and for consistency with other data fields in registry. Assessment of possible missing data fields. If measurement related, corrective and preventive actions shall be taken prior continuation of the study.
Data Registry
Data will be collected at the time of the bone density and ultrasound (DI) exams. Information collected will be entered into a database for statistical analysis. In addition to patient characteristics, 7 questions shall be presented to each patient to gather fracture risk related data (http://www.shef.ac.uk/FRAX):
- Previous fracture
- Parent fip fracture
- Current smoking
- Use of Glucocorticoids
- Rheumatoid arthritis
- Secondary osteoporosis
- Alcohol 3 or more units/day
Confidentiality
- Any of the data from this study will not be a part of permanent record (identifiable to the subject) that will be made available to physician, employer, supervisor, student, FDA, etc.
- Data will be kept in paper form indefinitely at HealthEast Osteoporosis Care. All research data is kept in locked cabinetry.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Men | – | –140 Men |
| Female | – | –500 Female |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- American-Caucasian female (n=500) American-Caucasian men (n=140)
Key inclusion criteria (1 listed)
- Postmenopausal women and men referred for bone density examination.
Key exclusion criteria (1 listed)
- Patients unable to sign consent for participation.
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
Threshold values for DI to reach 90% sensitivity and specificity with the method in diagnostics of Osteoporosis.
Time frame: 1 year
1 secondary outcome
Amount subjects that can be diagnosed with the established thresholds for DI. Amount of subjects that would require additional examination to verify diagnosis.Correlation between BMD at neck, total hip and lumbar spine with DI.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Institution not able to carry out research as of 2015). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
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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.
Christine Simonelli, MD principal investigator
HealthEast Osteoporosis Care
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 17 May 2017. 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 was stopped early (reason given: Institution not able to carry out research as of 2015). Results are not available in the source record.
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?
Threshold values for DI to reach 90% sensitivity and specificity with the method in diagnostics of Osteoporosis. (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 17 May 2017.