Role of the Protein Osteoprotegerin in the Bone Health of Women With Congenital Adrenal Hyperplasia
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|ClinicalTrials.gov Identifier: NCT00694525|
Recruitment Status : Unknown
Verified June 2009 by Office of Rare Diseases (ORD).
Recruitment status was: Recruiting
First Posted : June 10, 2008
Last Update Posted : June 2, 2009
|Condition or disease|
|Adrenal Hyperplasia, Congenital|
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.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Observational Model:||Case Control|
|Official Title:||Potential Modulatory Role of Osteoprotegerin in Bone Metabolism of Patients With 21-Hydroxylase Deficiency|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||June 2009|
|Estimated Study Completion Date :||June 2009|
Women in this group will have 21-OHD CAH.
Women in this group will be healthy controls and will not have 21-OHD CAH.
- Comparison of levels of OPG [ Time Frame: Measured throughout the study ]
- Comparison of bone mineral density [ Time Frame: Measured throughout the study ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694525
|Contact: Karen Lin Su, MDemail@example.com|
|United States, New York|
|Mount Sinai School of Medicine||Recruiting|
|New York, New York, United States, 10029|
|Principal Investigator: Karen Lin Su, MD|
|Sub-Investigator: Maria I. New, MD|
|Sub-Investigator: Saroj Nimkarn, MD|
|Sub-Investigator: Mone Zaidi, MD, PhD|
|Sub-Investigator: Henry Bone, MD|
|Study Chair:||Karen Lin Su, MD||Icahn School of Medicine at Mount Sinai|