OsteoporosisNCT01998737
Point-of-care Osteoporosis Diagnostics With Bindex® Pocket Size Instrument and FRAX
An observational study of Osteoporosis, run by Bone Index Finland Ltd at 6 sites in Finland.
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 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 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- How many people
- 1,011 participants
- Where
- 6 sitesFinland
- Study dates
- Nov 2013to Mar 2016
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 1100 postmenopausal women (age 50 -79 years) will participate the study. The subjects will be divided into two groups: healthy (100 women) and under osteoporosis suspicion (1000 women). The groups will be matched by BMI. Women for the under osteoporosis suspicion group will be invited from those who have got a referral for DXA examination from their doctor.
Who may be able to join
- Age: 50 - 59 years (n = 500) and 60-79 years (n = 500).
- Post-menopausal status.
- At least one of the clinical risk factors for fracture:
- Low body mass index (< 19kg/m2)
- Previous fragility fracture
- Parental history of hip fracture
Show all 21Show fewer
- Glucocorticoid treatment (≥ 5mg prednisolone daily or equivalent for 3 months or more)
- Current smoking
- Alcohol intake 3 or more units daily
- Causes of secondary osteoporosis:
- Untreated hypogonadism
- Inflammatory bowel disease
- Prolonged immobility
- Organ transplantation
- Type 1 and type 2 diabetes
- Thyroid disorders
- Chronic obstructive pulmonary disease
- A Physician has referred the woman to axial DXA investigation.
- Age: 50 - 59 years (n = 50) and 60-79 years (n = 50).
- Post-menopausal status.
- No diseases or treatments which may affect to bone health.
Who cannot join
- Treatment: osteoporosis medication.
- Obesity: body mass index BMI > 30kg/m2
- a refusal to participate in the study
- Healthy
- Treatment: osteoporosis medication.
- a refusal to participate in the study
- Obesity: body mass index BMI > 30kg/m2
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Finland6 sites
Terveystalo Kamppi
Helsinki
Terveystalo Jyväskylä
Jyväskylä, 40100
Terveystalo Kouvola
Kouvola, 45100
Kuopio University Hospital
Kuopio
Terveystalo Lahti
Lahti, 15110
Terveystalo Mikkeli Marski
Mikkeli, 50100
About this study
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 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.
In this study we aim to investigate the strength of Density Index (DI) for prediction of proximal femur and lumbar spine BMD as well as determining the diagnostic thresholds for DI for osteoporosis diagnostics by using the International Society for Clinical Densitometry guidelines. In addition we aim to investigate how many additional women would be identified for osteoporosis diagnosis/ treatment based on adding FRAX to Bindex versus adding FRAX to DXA.
Read more
The investigators will start and organize a multicenter study in 5 osteoporosis clinics in Suomen Terveystalo Healthcare Service Company in Finland. A total of 1100 postmenopausal women (age 50 -79 years) will be measured with both axial DXA and Bindex. In addition, the FRAX questioinnaire will be asked from everybody attending the study.
Clinical hypotheses:
- Cortical bone thickness is decreased in osteoporosis.
- Patient age, weight and height are related to BMD status and therefore are needed in BMD estimation (Density Index).
- Ultrasound is a safe method in osteoporosis screening and diagnostics for osteoporosis.
- Fracture risk factors (FRAX) and point-of-care bone density measurement together have significantly higher sensitivity and specificity for osteoporosis/treatment decisions than one method alone.
Read the detailed description
The following procedures will be applied
- Signing Informed Consent
- Filling in the FRAX questionnaire
- DXA measurements of the proximal femur and AP spine
- Bindex ultrasound measurement of both the tibia and the radius
Written informed consent is obtained from all subjects before enrolment to the study. All patient data is coded, i.e. made anonymous, to conform to personal data protection. The data is processed only for study purposes.
A total of 1100 postmenopausal women (age 50 -79 years) will participate the study. The subjects will be divided into two groups: healthy (100 women) and under osteoporosis suspicion (1000 women). The groups will be matched by BMI.
Written informed consent is obtained from all subjects before enrolment in the study. All patient data is coded, i.e. made anonymous, to conform to personal data protection. The data is processed only for study purposes.
- 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 |
|---|---|---|
| Women under osteoporosis suspicion | Not described | |
| Healthy women | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis
The thresholds for the Density Index (DI) in osteoporosis diagnostics in comparison to dual energy x-ray absorptiometry (DXA) are evaluated in independent population.
Measured: 3 years
Specificity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis
The thresholds for the Density Index (DI) in osteoporosis diagnostics in comparison to dual energy x-ray absorptiometry (DXA) are evaluated in independent population.
Measured: 3 years
Secondary outcomes (1)
Number of Participants That Would Require Additional DXA Examination to Confirm Diagnosis
The previously determined thresholds have been applied. The results show amount of subject whose DI value is between the thresholds. These subjects would need DXA measurement to verify diagnosis.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 1,011 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bone Index Finland Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Heikki Kröger, MD, PhD, Principal investigator, Kuopio University HospitalJanne P Karjalainen, PhD, Study director, Bone Index Finland LtdOssi Riekkinen, PhD, Study director, Bone Index Finland Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998737
- Sponsor's protocol ID
- Bind03
- Other IDs
- BoneIndex03
- Status last verified
- Aug 2017
- First submitted
- 25 Nov 2013
- Last updated
- 21 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-care Osteoporosis Diagnostics With Bindex® Pocket Size Instrument and FRAX
- ClinicalTrials.gov ID
- NCT01998737
- Acronym / sponsor ID
- Bind03
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, diagnostics, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,011 participants (actual)
- Lead sponsor
- Bone Index Finland LtdIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Nov 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 Dec 2013 (estimated)
- Results
- Posted 11 Aug 2017
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 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.
In this study we aim to investigate the strength of Density Index (DI) for prediction of proximal femur and lumbar spine BMD as well as determining the diagnostic thresholds for DI for osteoporosis diagnostics by using the International Society for Clinical Densitometry guidelines. In addition we aim to investigate how many additional women would be identified for osteoporosis diagnosis/ treatment based on adding FRAX to Bindex versus adding FRAX to DXA.
The investigators will start and organize a multicenter study in 5 osteoporosis clinics in Suomen Terveystalo Healthcare Service Company in Finland. A total of 1100 postmenopausal women (age 50 -79 years) will be measured with both axial DXA and Bindex. In addition, the FRAX questioinnaire will be asked from everybody attending the study.
Clinical hypotheses:
- Cortical bone thickness is decreased in osteoporosis.
- Patient age, weight and height are related to BMD status and therefore are needed in BMD estimation (Density Index).
- Ultrasound is a safe method in osteoporosis screening and diagnostics for osteoporosis.
- Fracture risk factors (FRAX) and point-of-care bone density measurement together have significantly higher sensitivity and specificity for osteoporosis/treatment decisions than one method alone.
Detailed description
The following procedures will be applied
- Signing Informed Consent
- Filling in the FRAX questionnaire
- DXA measurements of the proximal femur and AP spine
- Bindex ultrasound measurement of both the tibia and the radius
Written informed consent is obtained from all subjects before enrolment to the study. All patient data is coded, i.e. made anonymous, to conform to personal data protection. The data is processed only for study purposes.
A total of 1100 postmenopausal women (age 50 -79 years) will participate the study. The subjects will be divided into two groups: healthy (100 women) and under osteoporosis suspicion (1000 women). The groups will be matched by BMI.
Written informed consent is obtained from all subjects before enrolment in the study. All patient data is coded, i.e. made anonymous, to conform to personal data protection. The data is processed only for study purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women under osteoporosis suspicion | – | – |
| Healthy women | – | – |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 1100 postmenopausal women (age 50 -79 years) will participate the study. The subjects will be divided into two groups: healthy (100 women) and under osteoporosis suspicion (1000 women). The groups will be matched by BMI. Women for the under osteoporosis suspicion group will be invited from those who have got a referral for DXA examination from their doctor.
Key inclusion criteria (21 listed)
- Age: 50 - 59 years (n = 500) and 60-79 years (n = 500).
- Post-menopausal status.
- At least one of the clinical risk factors for fracture:
- Alcohol intake 3 or more units daily
- Causes of secondary osteoporosis:
Key exclusion criteria (7 listed)
- Treatment: osteoporosis medication.
- Obesity: body mass index BMI > 30kg/m2
- a refusal to participate in the study
- Healthy
- Treatment: osteoporosis medication.
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
Sensitivity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis
Time frame: 3 years
The thresholds for the Density Index (DI) in osteoporosis diagnostics in comparison to dual energy x-ray absorptiometry (DXA) are evaluated in independent population.
Specificity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis
Time frame: 3 years
The thresholds for the Density Index (DI) in osteoporosis diagnostics in comparison to dual energy x-ray absorptiometry (DXA) are evaluated in independent population.
1 secondary outcome
Number of Participants That Would Require Additional DXA Examination to Confirm Diagnosis
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
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.
Heikki Kröger, MD, PhD principal investigator
Kuopio University Hospital
Janne P Karjalainen, PhD study director
Bone Index Finland Ltd
Ossi Riekkinen, PhD study director
Bone Index Finland Ltd
6 sites 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 6 sites in Finland.
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 21 inclusion and 7 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 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Finland. 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?
Yes. Results are posted in the registry (first posted 11 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis (time frame: 3 years). The study lists 2 primary outcomes in all. 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 21 Sep 2017.