Age Dependend Diagnostic Thresholds for Osteoporosis Bindex Ultrasonometer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Park Nicollet Institute
Information provided by (Responsible Party):
Bone Index Finland Ltd
ClinicalTrials.gov Identifier:
NCT01978834
First received: October 28, 2013
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

This study is designed for clinical validation of the novel ultrasound device (Bindex®, Bone Index Finland Ltd.). In a preliminary study technique has been validated in Finnish elderly woman population with 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 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.

First, the thresholds for DI will be determined by measuring 70 osteoporotic and 70 healthy patients (n = 140) with Bindex and DXA within four decades of age; age 50 to 59 years, age 60 to 69 years, age 70 to 79 years, and age 80 to 89 years. The feasibility of DI for diagnostics of osteoporosis and evaluation of bone mineral density (BMD) will be assessed. The thresholds for the BMD estimate obtained with DI will be determined for osteoporotic and non-osteoporotic patients. For fracture risk assessment, DI measurements are used to predict the outcome of currently available fracture risk assessment tools.

  1. To investigate optimal configuration of ultrasound parameters and patient characteristics for prediction of proximal femur and lumbar spine BMD for women in each four decades of age; 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.
  2. To develop national diagnostic thresholds for DI in prediction of osteoporosis status with a reference female population (American-Caucasian) in each four decades of age; 50 to 59 years, 60 to 69 years, 70 to 79 years, and 80-89 years.

Condition
Osteoporosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Age Dependend Diagnostic Thresholds for Osteoporosis Bindex Ultrasonometer

Resource links provided by NLM:


Further study details as provided by Bone Index Finland Ltd:

Primary Outcome Measures:
  • Thresholds for Bindex in Osteoporosis Diagnostics [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Diagnostics thresholds for DI parameter for Osteoporosis within four decades of age; age 50 to 59 years, age 60 to 69 years, age 70 to 79 years, and age 80 to 89 years.


Estimated Enrollment: 560
Study Start Date: October 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Data will be stored by Park Nicollet Institute. Only data listed below will be given to the research team at Bindex for analyses.

The data for determination of diagnostic threshold for DI in North American population will be analyzed by Bone Index Finland. The data will include following parameters:

  • Age in years
  • Weight
  • Height
  • Cortical thickness values at each location
  • Density Index values
  • Raw data on ultrasound signals.
  • DXA measurement data
  • Identification code (Uniquely created identification code given to a subject, does not carry any information on subject but enables tracing if needed.)
  • Data from Appendix A, excluding patient name and medical record number

Risk factors will be collected in a separate questionnaire (Appendix A).

  1. Name
  2. Medical Record Number
  3. Weight (kg)
  4. Height (cm)
  5. Chair Stand test Can do easily; can do only with difficulty; cannot do

    Risk Factors:

  6. Previous fracture (Skeletal site, age at which fracture occured)
  7. Parent fractured hip (Yes, No)
  8. Current smoking (Yes, No)
  9. Glucocorticoid Use (Yes, No)
  10. Rheumatoid arthritis (Yes, No)
  11. Alcohol 3 or more units per day (Yes, No)
  12. Osteoporosis medication, type (e.g. alendronate, bisphosphonates), start- and end-date (Within the past five years)
  Eligibility

Ages Eligible for Study:   50 Years to 89 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Female (American-Caucasian)

Criteria

Inclusion Criteria:

  • Female sex
  • Age 50 to 89 years

Exclusion Criteria:

  • Those who have opted out of being contacted for research on their general Park Nicollet clinic consent will not be recruited by mail
  • Inability to sign consent form due to cognitive impairment. Those with dementia (ICD-9 diagnosis codes 331.0, 294.1, 294.10, 294.11, or 294.8) will excluded from mailed recruitment
  • Measurement of hip BMD is not feasible (for example, those who have had bilateral hip replacement surgeries or who cannot have central DXA because of their body weight)
  • Open leg or arm wounds at sites where ultrasound measurements are supposed to be taken, precluding such measurements
  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: NCT01978834

Locations
United States, Minnesota
Park Nicollet Institute
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
Bone Index Finland Ltd
Park Nicollet Institute
Investigators
Principal Investigator: John T Schousboe, MD, PhD Park Nicollet Institute
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: NCT01978834     History of Changes
Other Study ID Numbers: Bind02, BoneIndex02
Study First Received: October 28, 2013
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 21, 2014