Status:
UNKNOWN
Role of the Protein Osteoprotegerin in the Bone Health of Women With Congenital Adrenal Hyperplasia
Lead Sponsor:
Office of Rare Diseases (ORD)
Conditions:
Adrenal Hyperplasia, Congenital
Eligibility:
FEMALE
20-35 years
Brief Summary
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 hyperplas...
Detailed Description
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 us...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00694525
Start Date
April 1 2008
End Date
June 1 2009
Last Update
June 2 2009
Active Locations (1)
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1
Mount Sinai School of Medicine
New York, New York, United States, 10029