Osteoporosis, PostmenopausalNCT03878732
Bindex for Osteoporosis Diagnostics
An observational study of Osteoporosis, Postmenopausal, 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 most are diagnosed only after several fractures. Furthermore, the progressively aging population will increase the prevalence of osteoporosis. Read more about this study
- Who is it for?
- Ages 50 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Bindex measurement
- How many people
- 293 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2019to 7 Feb 2020
- 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 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Random sample of eligible female subjects who are being treated at collaborating clinic.
Who may be able to join
- Postmenopausal status
- Age at 50 years or over
- Caucasian or Hispanic race (number shall be controlled, 140 in each group)
- Body mass index (BMI < 35)
- Additional criteria for Osteoporotic group
- T-Score (NHANES database) -2.5 or lower at femoral neck or total femur
- Additional criteria for non-osteoporotic group
- T-Score (NHANES database) > -2.5 at femoral neck or total femur
Who cannot join
- for non-osteoporotic groups (Hispanic or Caucasian)
- Previous osteoporosis diagnosis
- Previous or current use of anti-fracture medication
Trial locations and contacts
1 site in 1 country.
United States1 site
New Mexico Clincial Research & Osteoporosis Center, Inc.
Albuquerque, New Mexico, 87106
About this study
Osteoporosis is a disease that leads to impaired skeletal strength and increased fracture risk. Among 200 million osteoporotic patients most are diagnosed only after several fractures. Furthermore, the progressively aging population will increase the prevalence of osteoporosis. It is estimated that over 75% of osteoporotic patients are not diagnosed and does not receive treatment for their condition. Bindex ultrasound device has been developed and validated in Caucasian female population. In this study, diagnostic thresholds for density index as determined with Bindex will be evaluated in two different ethnic populations.
Read the detailed description
Currently, the diagnosis of osteoporosis is based on the measurement of bone mineral density (BMD), using axial dual energy X-ray absorptiometry (DXA) of the hip and/or the lumbar spine at special healthcare.
Application of diagnostic thresholds determined against BMD have been suggested by International Society for Clinical Densitometry (ISCD) for use with peripheral bone densitometry devices (90% sensitivity and 90% specificity). These thresholds have been determined and validated for Bindex in Caucasian female population.
This study focuses on clinical validation of the ultrasound device (Bindex®, Bone Index Finland Ltd., www.boneindex.com) device and Density Index (DI), a diagnostic parameter reported by Bindex. The predetermined thresholds for DI will be evaluated by measuring 70 osteoporotic and 70 healthy patients with Bindex and DXA in each selected patient groups. The feasibility of DI for diagnostics of osteoporosis in these groups will be assessed.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- Bindex measurement
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bindex measurementDiagnostic test
One time bone density measurement with ultrasound device
| Study group | Role | What they receive |
|---|---|---|
| Caucasian female | Not described Receives: Diagnostic Test: Bindex measurement | |
| Hispanic female | Not described Receives: Diagnostic Test: Bindex measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of DI
Sensitivity and specificity of DI in caucasian and hispanic groups
Measured: 3/11/2019-11/29/2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start11 Mar 2019
- Primary completion7 Feb 2020
- Study completion7 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies 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
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bone Index Finland Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- New Mexico Clincial Research & Osteoporosis Center, Inc.
- Responsible party
- Sponsor
- Investigators
- Janne Karjalainen, Study chair, Bone Index Finland Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878732
- Sponsor's protocol ID
- Bind2301
- Status last verified
- Apr 2020
- First submitted
- 15 Mar 2019
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bindex for Osteoporosis Diagnostics
- ClinicalTrials.gov ID
- NCT03878732
- Acronym / sponsor ID
- Bind2301
- Conditions
- Osteoporosis, Postmenopausal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Bone Index Finland LtdIndustry (pharma, biotech, devices)
- Collaborators
- New Mexico Clincial Research & Osteoporosis Center, Inc.
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 18 Mar 2019 (actual)
- 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 most are diagnosed only after several fractures. Furthermore, the progressively aging population will increase the prevalence of osteoporosis. It is estimated that over 75% of osteoporotic patients are not diagnosed and does not receive treatment for their condition. Bindex ultrasound device has been developed and validated in Caucasian female population. In this study, diagnostic thresholds for density index as determined with Bindex will be evaluated in two different ethnic populations.
Detailed description
Currently, the diagnosis of osteoporosis is based on the measurement of bone mineral density (BMD), using axial dual energy X-ray absorptiometry (DXA) of the hip and/or the lumbar spine at special healthcare.
Application of diagnostic thresholds determined against BMD have been suggested by International Society for Clinical Densitometry (ISCD) for use with peripheral bone densitometry devices (90% sensitivity and 90% specificity). These thresholds have been determined and validated for Bindex in Caucasian female population.
This study focuses on clinical validation of the ultrasound device (Bindex®, Bone Index Finland Ltd., www.boneindex.com) device and Density Index (DI), a diagnostic parameter reported by Bindex. The predetermined thresholds for DI will be evaluated by measuring 70 osteoporotic and 70 healthy patients with Bindex and DXA in each selected patient groups. The feasibility of DI for diagnostics of osteoporosis in these groups will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caucasian female | – | Diagnostic Test: Bindex measurement |
| Hispanic female | – | Diagnostic Test: Bindex measurement |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Random sample of eligible female subjects who are being treated at collaborating clinic.
Key inclusion criteria (8 listed)
- Postmenopausal status
- Age at 50 years or over
- Caucasian or Hispanic race (number shall be controlled, 140 in each group)
- Body mass index (BMI < 35)
- Additional criteria for Osteoporotic group
Key exclusion criteria (3 listed)
- for non-osteoporotic groups (Hispanic or Caucasian)
- Previous osteoporosis diagnosis
- Previous or current use of anti-fracture medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bindex measurementOne time bone density measurement with ultrasound device | Diagnostic test | Caucasian female, Hispanic female |
Primary outcome
Sensitivity and specificity of DI
Time frame: 3/11/2019-11/29/2019
Sensitivity and specificity of DI in caucasian and hispanic groups
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 1 May 2020.
- Individual participant dataSharing planned: No
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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.
Janne Karjalainen study chair
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, Postmenopausal, 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 8 inclusion and 3 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 1 May 2020. 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?
Sensitivity and specificity of DI (time frame: 3/11/2019-11/29/2019). 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 1 May 2020.