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Bindex Ultrasonometer for Osteoporosis Diagnostics

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ClinicalTrials.gov Identifier: NCT01935232
Recruitment Status : Terminated (Institution not able to carry out research as of 2015)
First Posted : September 5, 2013
Last Update Posted : May 17, 2017
HealthEast Care System
Information provided by (Responsible Party):
Bone Index Finland Ltd

Brief 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. 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.

  1. To investigate the capability of DI for prediction of proximal femur and lumbar spine BMD;
  2. 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);
  3. To investigate ability of Density Index + FRAX with BMI in fracture risk prediction;
  4. 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.

Condition or disease

Detailed Description:


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):

  1. Previous fracture
  2. Parent fip fracture
  3. Current smoking
  4. Use of Glucocorticoids
  5. Rheumatoid arthritis
  6. Secondary osteoporosis
  7. Alcohol 3 or more units/day


  1. 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.
  2. Data will be kept in paper form indefinitely at HealthEast Osteoporosis Care. All research data is kept in locked cabinetry.

Study Type : Observational [Patient Registry]
Actual Enrollment : 135 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Validation of Bindex Bone Ultrasonometer for Osteoporosis Diagnostics
Actual Study Start Date : August 2013
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

140 Men
500 Female

Primary Outcome Measures :
  1. Threshold values for DI to reach 90% sensitivity and specificity with the method in diagnostics of Osteoporosis. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  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. [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
American-Caucasian female (n=500) American-Caucasian men (n=140)

Inclusion Criteria:

  • Postmenopausal women and men referred for bone density examination.

Exclusion Criteria:

  • Patients unable to sign consent for participation.

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): NCT01935232

United States, Minnesota
HealthEast Clinic
Saint Paul, Minnesota, United States, 55125
Sponsors and Collaborators
Bone Index Finland Ltd
HealthEast Care System
Principal Investigator: Christine Simonelli, MD HealthEast Osteoporosis Care
Study Director: Janne P Karjalainen, PhD Bone Index Finland Ltd
Study Director: Ossi Riekkinen, PhD Bone Index Finland Ltd

Responsible Party: Bone Index Finland Ltd
ClinicalTrials.gov Identifier: NCT01935232     History of Changes
Other Study ID Numbers: Bind01
BoneIndex01 ( Other Identifier: Bone Index Finland Ltd. )
First Posted: September 5, 2013    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017

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

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