Status:
COMPLETED
Does Bone Structure Explain the Increased Fracture Risk in Type II Diabetes Patients? A Pilot Study
Lead Sponsor:
University of California, San Francisco
Conditions:
Osteoporosis
Eligibility:
FEMALE
55-75 years
Brief 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 physi...
Eligibility Criteria
Inclusion
- Postmenopausal female, 55-75 years old
- History of Type II diabetes, as defined by the American Diabetes Association for more than 5 years that is either insulin requiring or treated with oral therapies such as sulfonylureas and metformin
- Body mass index (BMI) of 19-35
- Able to move without walkers and without a history of long periods (\>3 months) of inactivity
- Additional Inclusion criteria for fracture participants:
- Fractures of the proximal humerus and femur as well as the ankle and foot should have occurred after the onset of diabetes and should have been caused by a low energy trauma such as falling from standing height. All fractures will be verified by radiographs.
Exclusion
- Severe neuropathic disease such as neurogenic osteoarthropathies (i.e., Charcot joints) of the foot
- Steroid users or have disease conditions that could play a significant role in the development of osteoporosis such as idiopathic osteoporosis, immobilization, hyperparathyroidism, or hyperthyroidism
- Diseases that may affect bone metabolism: alcoholism, chronic drug use, chronic gastrointestinal disease, renal or hepatic impairment
- Chronic treatment with antacids, estrogen, adrenal or anabolic steroids, anticonvulsants, anticoagulants, or pharmacologic doses of Vitamin A supplements 6 months prior
- Diabetic patients on rosiglitazone or pioglitazone medications
- high energy trauma, e.g., due to motor vehicle accidents
- Pathological fractures of other origin, i.e., tumor, tumor-like lesions as well as focal demineralization visualized on radiographs
- History of fluoride, bisphosphonate, calcitonin or tamoxifen use
- History of unstable cardiovascular disease or uncontrolled hypertension
- MRI contraindications
- Body mass index greater than 35
Key Trial Info
Start Date :
May 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00703417
Start Date
May 1 2006
End Date
July 1 2009
Last Update
June 8 2011
Active Locations (1)
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1
China Basin Imaging Center
San Francisco, California, United States, 94107