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Role of the Protein Osteoprotegerin in the Bone Health of Women With Congenital Adrenal Hyperplasia

2009年6月1日 更新者:Office of Rare Diseases (ORD)

Potential Modulatory Role of Osteoprotegerin in Bone Metabolism of Patients With 21-Hydroxylase Deficiency

21-hydroxylase deficiency (21-OHD) is an inherited disorder that results from a mutation on the CYP21A2 gene. It affects the adrenal glands and is the most common cause of congenital adrenal hyperplasia (CAH). 21-OHD CAH causes the body to produce an insufficient amount of cortisol and an excess of androgen, the type of hormone that produces male characteristics. The primary treatment for 21-OHD CAH, glucocorticoid replacement therapy, has been shown to cause bone loss. However, the elevated hormone levels caused by 21-OHD CAH may increase production of the protein osteoprotegerin (OPG), which in turn may protect against bone loss. This study will compare bone density and OPG levels in women who have 21-OHD CAH and have undergone a lifetime of glucocorticoid replacement therapy to that in women who have neither of these criteria. In doing so, the study will aim to determine the relationship between OPG and bone loss.

研究概览

地位

未知

详细说明

Because of the excess of androgen caused by 21-OHD CAH, women with CAH may exhibit some male-like characteristics. Glucocorticoids are a member of a class of drugs called corticosteroids, which are used in hormone replacement therapy. In order to counteract the effects of 21-OHD CAH, women with the disease are given hormone replacement therapy with glucocorticoids beginning at infancy. Glucocorticoids are known to cause bone loss. Despite many years of treatment with glucocorticoids, however, young women with 21-OHD CAH seem to be protected against bone loss. Researchers believe that the increased androgen levels in these women leads to increased estrogen levels, which in turn increases OPG production. The increase in OPG levels may protect women against bone loss. This study will evaluate bone density and OPG levels in women with and without 21-OHD CAH to determine the relationship between OPG and bone loss.

Participants in this observational study will attend only one study visit. At this visit, they will undergo a blood draw; a scan of their lower spine, hip, and forearm; height and weight measurements; and a body fat analysis test. This last test will entail a weak and painless electrical signal being sent from foot to foot. Participants will not attend any follow-up visits for this study.

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。

学习联系方式

  • 姓名:Karen Lin Su, MD

学习地点

    • New York
      • New York、New York、美国、10029
        • 招聘中
        • Mount Sinai School of Medicine
        • 副研究员:
          • Saroj Nimkarn, MD
        • 首席研究员:
          • Karen Lin Su, MD
        • 副研究员:
          • Maria I. New, MD
        • 副研究员:
          • Mone Zaidi, MD, PhD
        • 副研究员:
          • Henry Bone, MD

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

20年 至 35年 (成人)

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

概率样本

研究人群

Premenopausal women between the ages of 20 and 35 who have 21-OHD CAH or do not have 21-OHD CAH.

描述

Inclusion Criteria:

For People with 21-OHD CAH:

  • 21-OHD CAH has been documented by molecular genetic analysis (mutations on CYP21A2 gene on both parental alleles)
  • Treatment with glucocorticoid replacement since infancy (begun within the first year)
  • Available hormonal data and treatment details over the 5 years prior to study entry
  • Premenopausal

For Healthy Controls:

  • No diagnosis of 21-OHD CAH, as confirmed by molecular genetic analysis
  • No first degree relative is enrolled as a 21-OHD CAHparticipant
  • Premenopausal

Exclusion Criteria:

  • Medical disorder or treatment with medications known to affect bone density (other than glucocorticoids for 21-OHD CAH patients), including, but not limited to growth hormone, IGF-I, depo-medroxyprogesterone acetate, biphosphonates, oral contraceptives, androgens, thyroxine, or aromatase inhibitors
  • Pregnant
  • Any smoking within the 6 months prior to study entry
  • Cardiac pacemaker or other implanted electronic medical device

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

队列和干预

团体/队列
1
Women in this group will have 21-OHD CAH.
2
Women in this group will be healthy controls and will not have 21-OHD CAH.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Comparison of levels of OPG
大体时间:Measured throughout the study
Measured throughout the study

次要结果测量

结果测量
大体时间
Comparison of bone mineral density
大体时间:Measured throughout the study
Measured throughout the study

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。

调查人员

  • 学习椅:Karen Lin Su, MD、Icahn School of Medicine at Mount Sinai

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2008年4月1日

初级完成 (预期的)

2009年6月1日

研究完成 (预期的)

2009年6月1日

研究注册日期

首次提交

2008年6月6日

首先提交符合 QC 标准的

2008年6月9日

首次发布 (估计)

2008年6月10日

研究记录更新

最后更新发布 (估计)

2009年6月2日

上次提交的符合 QC 标准的更新

2009年6月1日

最后验证

2009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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