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临床试验/NCT01724489
NCT01724489已完成不适用

Skeletal Physiology Dysregulation in Obesity: The Role of Growth Hormone

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
77
试验地点
1
主要终点
Bone Mineral Density

研究概览

简要总结

Obesity is an important risk factor for osteoporosis and fractures. With the growing prevalence of obesity in the U.S., understanding the pathophysiology of bone loss in this population is of importance to public health. Growth hormone (GH) is a critical mediator of bone homeostasis and is markedly reduced in obesity. Our preliminary data suggest an important role for the GH/insulin-like growth factor 1 (IGF-1) system in the pathogenesis of bone loss in obesity. The development of novel imaging techniques provides an opportunity to investigate the effects of GH on skeletal structure and strength, which will provide insights into the pathogenesis of obesity related bone loss. Understanding the pathophysiology of bone loss in obesity may help identify new treatment targets for this important complication. The investigator hypothesizes that low-dose GH administration for 18 months will improve skeletal health.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 18-65 and generally healthy
  • BMI ≥ 25 kg/m2
  • Bone mineral density (BMD) T score ≤ -1.0 and > -2.5 (as measured by DXA)

排除标准

  • For women: amenorrhea for 3 months, pregnancy or breastfeeding, polycystic ovary syndrome
  • History of diabetes mellitus, cancer or other serious chronic disease
  • Use of osteoporosis medications

研究组 & 干预措施

Growth Hormone

Active Comparator

Growth Hormone is Genotropin, provided by Pfizer Inc. It is self administered daily for 18 months using a 5 mg injection pen device. Dose will be titrated based on IGF-1 levels.

干预措施: Growth hormone (Drug)

Placebo

Placebo Comparator

Placebo will be provided by Pfizer Inc. It will appear identical to active growth hormone and will be administered in the same manner.

干预措施: Placebo (Drug)

结局指标

主要结局

Bone Mineral Density

时间窗: baseline and 18 months

Change in BMD over 18 months in the GH vs placebo group

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen Klahr Miller, MD

Chief, Neuroendocrine Unit

Massachusetts General Hospital

研究点 (1)

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