Role of the Protein Osteoprotegerin in the Bone Health of Women With Congenital Adrenal Hyperplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Altered Calcium and Vitamin D in PMDD or Severe PMS

NCT00005119

Premenstrual Syndrome

COMPLETED NA

BBD Longitudinal Study of Osteogenesis Imperfecta

NCT02432625

Osteogenesis Imperfecta

RECRUITING

Skeletal Maturation and Endocrine Health in Young Adults

NCT06509776

Osteoporosis Sarcopenia Obesity +1 more

ENROLLING_BY_INVITATION

Low Energy Availability, Menstrual Irregularity, and Low Bone Mass

NCT01059968

Bone Density Energy Availability

COMPLETED

Natural History of the Collagen-Related Disorder Osteogenesis Imperfecta and Genotype Phenotype Correlation

NCT03575221

Osteogenesis Imperfecta Short Stature

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adrenal Hyperplasia, Congenital

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Women in this group will have 21-OHD CAH.

No interventions assigned to this group

2

Women in this group will be healthy controls and will not have 21-OHD CAH.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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 Criteria

* 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes