Bindex Ultrasonometer for Osteoporosis Diagnostics
| Status: | Terminated |
|---|---|
| Conditions: | Osteoporosis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 20 - 90 |
| Updated: | 5/18/2017 |
| Start Date: | August 2013 |
| End Date: | December 2014 |
Validation of Bindex Bone Ultrasonometer for Osteoporosis Diagnostics
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.
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.
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.
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.
Inclusion Criteria:
- Postmenopausal women and men referred for bone density examination.
Exclusion Criteria:
- Patients unable to sign consent for participation.
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