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Does Bone Structure Explain the Increased Fracture Risk in Type II Diabetes Patients? A Pilot Study

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00703417
First received: June 19, 2008
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Osteoporosis
Device: magnetic Resonance Imaging
Device: Computed Tomography
Device: High resolution peripheral quantitative computed tomography

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Does Bone Structure Explain the Increased Fracture Risk in Type II Diabetes Patients? A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Estimated Enrollment: 40
Study Start Date: May 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Healthy post-menopausal women
Device: magnetic Resonance Imaging
MRI of the calcaneus, the distal tibia, the distal radius and also lower back.
Device: High resolution peripheral quantitative computed tomography
HR-pQCT of the distal radius and distal tibia
2
Diabetic without fracture
Device: magnetic Resonance Imaging
MRI of the calcaneus, the distal tibia, the distal radius and also lower back.
Device: Computed Tomography
CT scan of the lower back and hip
Device: High resolution peripheral quantitative computed tomography
HR-pQCT of the distal radius and distal tibia
3
Diabetic with fracture
Device: magnetic Resonance Imaging
MRI of the calcaneus, the distal tibia, the distal radius and also lower back.
Device: Computed Tomography
CT scan of the lower back and hip
Device: High resolution peripheral quantitative computed tomography
HR-pQCT of the distal radius and distal tibia

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703417

Locations
United States, California
China Basin Imaging Center
San Francisco, California, United States, 94107
Sponsors and Collaborators
University of California, San Francisco
  More Information

No publications provided

Responsible Party: Thomas M. Link, M.D., University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00703417     History of Changes
Other Study ID Numbers: Diabetes
Study First Received: June 19, 2008
Last Updated: June 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
osteoporosis
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 27, 2014