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

2011年6月6日 更新者:University of California, San Francisco

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.

研究概览

研究类型

观察性的

注册 (预期的)

40

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • San Francisco、California、美国、94107
        • China Basin Imaging Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

55年 至 75年 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

取样方法

概率样本

研究人群

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

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:病例对照
  • 时间观点:预期

队列和干预

团体/队列
干预/治疗
1
Healthy post-menopausal women
MRI of the calcaneus, the distal tibia, the distal radius and also lower back.
HR-pQCT of the distal radius and distal tibia
2
Diabetic without fracture
MRI of the calcaneus, the distal tibia, the distal radius and also lower back.
HR-pQCT of the distal radius and distal tibia
CT scan of the lower back and hip
3
Diabetic with fracture
MRI of the calcaneus, the distal tibia, the distal radius and also lower back.
HR-pQCT of the distal radius and distal tibia
CT scan of the lower back and hip

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年5月1日

初级完成 (实际的)

2009年7月1日

研究完成 (实际的)

2009年7月1日

研究注册日期

首次提交

2008年6月19日

首先提交符合 QC 标准的

2008年6月20日

首次发布 (估计)

2008年6月23日

研究记录更新

最后更新发布 (估计)

2011年6月8日

上次提交的符合 QC 标准的更新

2011年6月6日

最后验证

2011年6月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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