Age Dependend Diagnostic Thresholds for Osteoporosis Bindex Ultrasonometer

NCT01978834 | Completed

• 2 other identifiers: Bind02BoneIndex02
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

Osteoporosis

Keywords

Osteoporosis, diagnosis, ultrasound

Outcome Measures

Primary Outcomes (1)

• Thresholds for Bindex in Osteoporosis Diagnostics

  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.

  1 year

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female (American-Caucasian)

You may qualify if:

• Female sex
• Age 50 to 89 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Bone Index Finland Ltd: lead
• HealthPartners Institute: collaborator

Study Sites (1)

Park Nicollet Institute

Minneapolis, Minnesota, 55416, United States

Location

MeSH Terms

Conditions

Osteoporosis; Disease

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John T Schousboe, MD, PhD

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

• Janne P Karjalainen, PhD

  Bone Index Finland Ltd

  STUDY DIRECTOR

• Ossi Riekkinen, PhD

  Bone Index Finland Ltd

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 8, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 29, 2015

Record last verified: 2015-01

Locations

US (1)