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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Page 1 of 1 (1 locations)

1

Mount Sinai School of Medicine

New York, New York, United States, 10029