Role of the Protein Osteoprotegerin in the Bone Health of Women With Congenital Adrenal Hyperplasia
Potential Modulatory Role of Osteoprotegerin in Bone Metabolism of Patients With 21-Hydroxylase Deficiency
研究概览
地位
条件
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
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Karen Lin Su, MD
学习地点
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-
New York
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New York、New York、美国、10029
- 招聘中
- Mount Sinai School of Medicine
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副研究员:
- Saroj Nimkarn, MD
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首席研究员:
- Karen Lin Su, MD
-
副研究员:
- Maria I. New, MD
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副研究员:
- Mone Zaidi, MD, PhD
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副研究员:
- Henry Bone, MD
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
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
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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1
Women in this group will have 21-OHD CAH.
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2
Women in this group will be healthy controls and will not have 21-OHD CAH.
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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
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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
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Measured throughout the study
|
合作者和调查者
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
一般刊物
- Canalis E, Bilezikian JP, Angeli A, Giustina A. Perspectives on glucocorticoid-induced osteoporosis. Bone. 2004 Apr;34(4):593-8. doi: 10.1016/j.bone.2003.11.026. No abstract available.
- Paganini C, Radetti G, Livieri C, Braga V, Migliavacca D, Adami S. Height, bone mineral density and bone markers in congenital adrenal hyperplasia. Horm Res. 2000;54(4):164-8. doi: 10.1159/000053253.
- King JA, Wisniewski AB, Bankowski BJ, Carson KA, Zacur HA, Migeon CJ. Long-term corticosteroid replacement and bone mineral density in adult women with classical congenital adrenal hyperplasia. J Clin Endocrinol Metab. 2006 Mar;91(3):865-9. doi: 10.1210/jc.2005-0745. Epub 2005 Nov 8.
- Kudlacek S, Schneider B, Woloszczuk W, Pietschmann P, Willvonseder R; Austrian Study Group on Normative Values of Bone Metabolism. Serum levels of osteoprotegerin increase with age in a healthy adult population. Bone. 2003 Jun;32(6):681-6. doi: 10.1016/s8756-3282(03)00090-5.
- Hagenfeldt K, Martin Ritzen E, Ringertz H, Helleday J, Carlstrom K. Bone mass and body composition of adult women with congenital virilizing 21-hydroxylase deficiency after glucocorticoid treatment since infancy. Eur J Endocrinol. 2000 Nov;143(5):667-71. doi: 10.1530/eje.0.1430667.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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