Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-28 @ 11:21 AM
Study NCT ID:
NCT01978834
Status:
COMPLETED
Last Update Posted:
2015-01-29
First Post:
2013-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Age Dependend Diagnostic Thresholds for Osteoporosis Bindex Ultrasonometer
Sponsor:
Bone Index Finland Ltd
Organization:
Study Overview
Official Title:
Age Dependend Diagnostic Thresholds for Osteoporosis Bindex Ultrasonometer
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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. 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.
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.
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)
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)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| BoneIndex02 | OTHER | Bone Index Finland Ltd. | View |