Point-of-care Osteoporosis Diagnostics With Bindex® Pocket Size Instrument and FRAX
NCT ID: NCT01998737
Last Updated: 2017-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
1011 participants
OBSERVATIONAL
2013-11-30
2016-03-31
Brief Summary
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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:
1. Cortical bone thickness is decreased in osteoporosis.
2. Patient age, weight and height are related to BMD status and therefore are needed in BMD estimation (Density Index).
3. Ultrasound is a safe method in osteoporosis screening and diagnostics for osteoporosis.
4. 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
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* 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
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Women under osteoporosis suspicion
No interventions assigned to this group
Healthy women
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
Exclusion Criteria
* 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
50 Years
79 Years
FEMALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Bone Index Finland Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Heikki Kröger, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kuopio University Hospital
Janne P Karjalainen, PhD
Role: STUDY_DIRECTOR
Bone Index Finland Ltd
Ossi Riekkinen, PhD
Role: STUDY_DIRECTOR
Bone Index Finland Ltd
Locations
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Terveystalo Kamppi
Helsinki, , Finland
Terveystalo Jyväskylä
Jyväskylä, , Finland
Terveystalo Kouvola
Kouvola, , Finland
Kuopio University Hospital
Kuopio, , Finland
Terveystalo Lahti
Lahti, , Finland
Terveystalo Mikkeli Marski
Mikkeli, , Finland
Countries
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Other Identifiers
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BoneIndex03
Identifier Type: OTHER
Identifier Source: secondary_id
Bind03
Identifier Type: -
Identifier Source: org_study_id