Bone Mass Accrual in Adolescent Athletes
Summary
The adolescent and young adult years are a critical window in time for bone mineral accrual. More than 90% of peak bone mass is achieved by 18 years, and data indicate that insults sustained during adolescence and young adulthood may result in permanent deficits in bone accrual. Adult athletes with amenorrhea (AA) have low bone mineral density (BMD) secondary to hypogonadism, associated with increased fracture risk and associated co-morbidities. We will examine whether estrogen replacement will increase BMD and improve measures of bone microarchitecture in adolescents and young women with AA, thus optimizing peak bone mass.
Description
Young female athletes 18-21 years old will be randomized to estrogen (and progesterone) with lifestyle modification versus lifestyle modification alone for a 12 month period. Bone density and structure will be assessed over this period. Hormonal evaluations will also be performed.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Amenorrhea
Intervention
Estrogen
Location
Massachusetts General Hospital
Boston
Massachusetts
United States
02114
Status
Recruiting
Source
Massachusetts General Hospital
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00827151
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Estrogen Receptor Alpha
One of the ESTROGEN RECEPTORS that has marked affinity for ESTRADIOL. Its expression and function differs from, and in some ways opposes, ESTROGEN RECEPTOR BETA.
Raloxifene
A second generation selective estrogen receptor modulator (SERM) used to prevent osteoporosis in postmenopausal women. It has estrogen agonist effects on bone and cholesterol metabolism but behaves as a complete estrogen antagonist on mammary gland and uterine tissue.
Estrogen Replacement Therapy
The use of hormonal agents with estrogen-like activity in postmenopausal or other estrogen-deficient women to alleviate effects of hormone deficiency, such as vasomotor symptoms, DYSPAREUNIA, and progressive development of OSTEOPOROSIS. This may also include the use of progestational agents in combination therapy.
Estrogen Receptor Beta
One of the ESTROGEN RECEPTORS that has greater affinity for ISOFLAVONES than ESTROGEN RECEPTOR ALPHA does. There is great sequence homology with ER alpha in the DNA-binding domain but not in the ligand binding and hinge domains.
Tamoxifen
One of the SELECTIVE ESTROGEN RECEPTOR MODULATORS with tissue-specific activities. Tamoxifen acts as an anti-estrogen (inhibiting agent) in the mammary tissue, but as an estrogen (stimulating agent) in cholesterol metabolism, bone density, and cell proliferation in the ENDOMETRIUM.
Clinical Trials
Study of Leptin for the Treatment of Hypothalamic Amenorrhea
The purpose of this study is to determine whether administration of an investigational medication called leptin (r-metHuLeptin) in replacement doses can improve bone health, reproductive f...
Menstrual Cycle Maintenance and Quality of Life: A Prospective Study
Very little is known about the incidence, onset, time course, and symptomatology of premature menopause induced by breast cancer therapy. No prospective study exists. The purpose of the pr...
Postmenopausal Women Estrogen and Progesterone Infusion
The purpose of the study is to study the effects of aging, estrogen and progesterone on the brain. Specifically, we want to look at how the hypothalamus and pituitary (two small glands in...
Hormone Dynamics and Bone Mineral Density in Anorexia Nervosa v. Hypothalamic Amenorrhea
The purpose of this study is to determine whether the hormone dynamics in women with anorexia nervosa and hypothalamic amenorrhea is related to bone loss in those populations.
Evaluating the Roles of Estrogen and Progesterone in Heart Metabolism
Estrogen and progesterone are two main female sex hormones. When a woman goes through menopause, the body's production of estrogen and progesterone significantly decreases. Recent studies...
PubMed Articles
Amenorrhea from Breast Cancer Therapy - Not a Matter of Dose.
To the Editor: In our article on concurrent versus sequential administration of chemotherapy drugs for women with operable, node-positive, early-stage breast cancer (June 3 issue),(1) we report that p...
A genetic basis for functional hypothalamic amenorrhea.
Functional hypothalamic amenorrhea is a reversible form of gonadotropin-releasing hormone (GnRH) deficiency commonly triggered by stressors such as excessive exercise, nutritional deficits, or psychol...
Estrogen signaling and cardiovascular disease.
Estrogen has pleiotropic effects on the cardiovascular system. The mechanisms by which estrogen confers these pleiotropic effects are undergoing active investigation. Until a decade ago, all estrogen...
PURPOSE Premenopausal women with breast cancer receiving adjuvant chemotherapy are at risk for amenorrhea. The National Surgical Adjuvant Breast and Bowel Project B-30 trial included menstrual history...
OBJECTIVE: To determine the genetic cause of primary amenorrhea. DESIGN: Case series. PATIENTS: Three adolescents and one young woman 46, XY patients with srd5A2 gene mutations. SETTING: Pediatric end...
