Bindex Ultrasonometer for Osteoporosis Diagnostics

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
HealthEast Care System
Information provided by (Responsible Party):
Bone Index Finland Ltd
ClinicalTrials.gov Identifier:
NCT01935232
First received: August 21, 2013
Last updated: May 7, 2014
Last verified: May 2014
  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 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
Osteoporosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Validation of Bindex Bone Ultrasonometer for Osteoporosis Diagnostics

Resource links provided by NLM:


Further study details as provided by Bone Index Finland Ltd:

Primary Outcome Measures:
  • Threshold values for DI to reach 90% sensitivity and specificity with the method in diagnostics of Osteoporosis. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 640
Study Start Date: August 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Men
140 Men
Female
500 Female

Detailed Description:

Quality

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

Confidentiality

  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.
  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

American-Caucasian female (n=500) American-Caucasian men (n=140)

Criteria

Inclusion Criteria:

  • Postmenopausal women and men referred for bone density examination.

Exclusion Criteria:

  • Patients unable to sign consent for participation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01935232

Locations
United States, Minnesota
HealthEast Clinic
St. Paul, Minnesota, United States, 55125
Sponsors and Collaborators
Bone Index Finland Ltd
HealthEast Care System
Investigators
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
  More Information

No publications provided

Responsible Party: Bone Index Finland Ltd
ClinicalTrials.gov Identifier: NCT01935232     History of Changes
Other Study ID Numbers: Bind01, BoneIndex01
Study First Received: August 21, 2013
Last Updated: May 7, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 19, 2014