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Point-of-care Osteoporosis Diagnostics With Bindex® Pocket Size Instrument and FRAX

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01998737
First Posted: December 2, 2013
Last Update Posted: September 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Bone Index Finland Ltd
  Purpose

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:

  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.

Condition
Osteoporosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Point-of-care Osteoporosis Diagnostics With Bindex® Pocket Size Instrument and FRAX

Resource links provided by NLM:


Further study details as provided by Bone Index Finland Ltd:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Number of Participants That Would Require Additional DXA Examination to Confirm Diagnosis [ Time Frame: 3 years ]
    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.


Enrollment: 1011
Study Start Date: November 2013
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Women under osteoporosis suspicion
Healthy women

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Osteoporosis suspicion

Inclusion Criteria:

  • 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
    • 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.

Exclusion Criteria:

  • Treatment: osteoporosis medication.
  • Obesity: body mass index BMI > 30kg/m2
  • a refusal to participate in the study

Healthy

Inclusion Criteria:

  • 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:

  • Treatment: osteoporosis medication.
  • a refusal to participate in the study
  • Obesity: body mass index BMI > 30kg/m2
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01998737


Locations
Finland
Terveystalo Kamppi
Helsinki, Finland
Terveystalo Jyväskylä
Jyväskylä, Finland, 40100
Terveystalo Kouvola
Kouvola, Finland, 45100
Kuopio University Hospital
Kuopio, Finland
Terveystalo Lahti
Lahti, Finland, 15110
Terveystalo Mikkeli Marski
Mikkeli, Finland, 50100
Sponsors and Collaborators
Bone Index Finland Ltd
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Heikki Kröger, MD, PhD Kuopio University Hospital
Study Director: Janne P Karjalainen, PhD Bone Index Finland Ltd
Study Director: Ossi Riekkinen, PhD Bone Index Finland Ltd
  More Information

Responsible Party: Bone Index Finland Ltd
ClinicalTrials.gov Identifier: NCT01998737     History of Changes
Other Study ID Numbers: Bind03
BoneIndex03 ( Other Identifier: Bone Index Finland Ltd. )
First Submitted: November 25, 2013
First Posted: December 2, 2013
Results First Submitted: November 4, 2016
Results First Posted: August 11, 2017
Last Update Posted: September 21, 2017
Last Verified: August 2017

Keywords provided by Bone Index Finland Ltd:
Osteoporosis, diagnostics, ultrasound

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases