Role of the Protein Osteoprotegerin in the Bone Health of Women With Congenital Adrenal Hyperplasia
Recruitment status was Recruiting
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.
Adrenal Hyperplasia, Congenital
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Potential Modulatory Role of Osteoprotegerin in Bone Metabolism of Patients With 21-Hydroxylase Deficiency|
- Comparison of levels of OPG [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
- Comparison of bone mineral density [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
With participant's permission, 5 mL of blood will be stored for potential new blood markers in the future.
|Study Start Date:||April 2008|
|Estimated Study Completion Date:||June 2009|
|Estimated Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Women in this group will have 21-OHD CAH.
Women in this group will be healthy controls and will not have 21-OHD CAH.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694525
|Contact: Karen Lin Su, MDfirstname.lastname@example.org|
|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|