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NCT01935232 · ClinicalTrials.gov registry record
Bindex Ultrasonometer for Osteoporosis Diagnostics
A clinical trial, sponsored by Bone Index Finland.
- Terminated
- Registry status
- 135
- Enrollment target
NCT01935232: Clinical Trial study, sponsored by Bone Index Finland.
NCT01935232 is a clinical trial that was terminated before completion, run by Bone Index Finland. The registered enrollment target is 135 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01935232 was terminated before completion, sponsored by Bone Index Finland.
- TERMINATED
- Registry status
- 135 participants
- Enrollment target
Study Summary
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 osteop
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-12 |
Why NCT01935232 stopped before completion
NCT01935232 is an observational study that tracks outcomes without assigning an intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01935232 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01935232 about?
NCT01935232 is a clinical study titled "Bindex 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 os...
What is the current status of trial NCT01935232?
This trial is currently terminated. The enrollment target is 135 participants. The study started on 2013-08. Estimated completion is 2014-12.
Who is sponsoring clinical trial NCT01935232?
This trial is sponsored by Bone Index Finland, which has 3 total clinical trials registered on ClinicalTrials.gov.
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