Does Bone Structure Explain the Increased Fracture Risk in Type II Diabetes Patients? A Pilot Study
1 other identifier
observational
40
1 country
1
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 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 our understanding of the pathophysiology of diabetic bone disease and the prediction of fracture risk in an elderly diabetic population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2006
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 19, 2008
CompletedFirst Posted
Study publicly available on registry
June 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedJune 8, 2011
June 1, 2011
3.2 years
June 19, 2008
June 6, 2011
Conditions
Keywords
Study Arms (3)
1
Healthy post-menopausal women
2
Diabetic without fracture
3
Diabetic with fracture
Interventions
MRI of the calcaneus, the distal tibia, the distal radius and also lower back.
HR-pQCT of the distal radius and distal tibia
Eligibility Criteria
10 healthy postmenopausal women 10 postmenopausal women with Type II Diabetes and without fracture 10 postmenopausal women with Type II Diabetes and with fracture of the long bone of the upper arm, hip, ankle, or foot 10 postmenopausal women with Type II Diabetes with and without fracture
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Basin Imaging Center
San Francisco, California, 94107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 19, 2008
First Posted
June 23, 2008
Study Start
May 1, 2006
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
June 8, 2011
Record last verified: 2011-06