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NCT00703417 · ClinicalTrials.gov registry record
Does Bone Structure Explain the Increased Fracture Risk in Type II Diabetes Patients? A Pilot Study
A clinical trial, sponsored by University of California, San Francisco.
- Completed
- Registry status
- 40
- Enrollment target
NCT00703417 is a clinical trial that has completed, run by University of California, San Francisco. The registered enrollment target is 40 participants.
The verdict
NCT00703417 has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- 40 participants
- Enrollment target
Study Summary
For this cross-sectional case control pilot study 30 women, 55-75 years old with type II diabetes will be recruited. Diabetes will be defined as self-report of diabetes previously diagnosed by a physician, use of hypoglycemic medications, or fasting glucose \> 126 mg/dl (7.0mM) in accordance with the American Diabetes Association criteria. The diabetic patient population will be divided into 2 groups: patients with status post low energy fractures of the proximal humerus, the proximal femur, the ankle and the foot (n=10) versus diabetic patients with no fractures or low energy trauma fracture history (n=10). An additional group of 10 diabetic postmenopausal women will be recruited and will have magnetic resonance imaging (MRI) of the lower back only. Caucasian, Asian and Hispanic women will be combined since a previous study suggested that BMD is very similar in these 3 population and that ethnic differences are minimal. In addition a population of 10 age-matched, BMI-matched, race-matched healthy women, without osteoporotic fractures will be examined. In all of these volunteers a medical history will be obtained to ensure good health status and rule out chronic diseases that would have an impact on bone metabolism. Patients will undergo MRI, QCT and high-resolution peripheral quantitative computed tomography (HR-pQCT) examinations to determine bone mineral density and bone structure/quality. The hypothesis of this pilot project is that type II diabetic patients with and without low-energy fractures have a different trabecular bone architecture and composition, which is also different when compared to normal age-matched healthy patients. Architectural differences in these three patient groups may be visualized with high resolution MRI and high-resolution peripheral quantitative computed tomography (HR-pQCT) and will be most pronounced at the calcaneus and the distal tibia. Analyzing structure parameters obtained from high resolution MRI and spectroscopy may improve
Interventions
- DEVICE Computed Tomography
- DEVICE magnetic Resonance Imaging
- DEVICE High resolution peripheral quantitative computed tomography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2006-05 |
| Est. Completion | 2009-07 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00703417
The ClinicalTrials.gov registry entry for NCT00703417 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Computed Tomography is the first listed.
NCT00703417 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00703417 about?
NCT00703417 is a clinical study titled "Does Bone Structure Explain the Increased Fracture Risk in Type II Diabetes Patients? A Pilot Study". For this cross-sectional case control pilot study 30 women, 55-75 years old with type II diabetes will be recruited. Diabetes will be defined as self-report of diabetes previously diagnosed by a physician, use of hypoglycemic medications, or fasting glucose \> 126 mg/dl (7.0mM) in accordance with th...
What is the current status of trial NCT00703417?
This trial is currently completed. The enrollment target is 40 participants. The study started on 2006-05. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00703417?
The interventions under investigation include: Computed Tomography (DEVICE), magnetic Resonance Imaging (DEVICE), High resolution peripheral quantitative computed tomography (DEVICE).
Who is sponsoring clinical trial NCT00703417?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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