Role of the Protein Osteoprotegerin in the Bone Health of Women With Congenital Adrenal Hyperplasia
Status unconfirmed
Conditions studied: Adrenal Hyperplasia, Congenital
In brief
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.
Key facts
- Study ID
- NCT00694525
- Run by
- Office of Rare Diseases (ORD)
- People needed
- 40
- Starts
- 2008-04-01
- Expected to finish
- 2009-06-01
- Last updated by the study team
- 2009-06-02
Who can join
Age: 20 and older, up to 35. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mount Sinai School of Medicine — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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