Osteoporosis Clinical Trial
Official title:
Age Dependend Diagnostic Thresholds for Osteoporosis Bindex Ultrasonometer
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.
Status | Completed |
Enrollment | 560 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 50 Years to 89 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | Park Nicollet Institute | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Bone Index Finland Ltd | HealthPartners Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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