Bone Mass Accrual in Adolescent Athletes
| Status: | Withdrawn |
|---|---|
| Conditions: | Osteoporosis, Orthopedic, Women's Studies, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Rheumatology, Orthopedics / Podiatry, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 21 |
| Updated: | 2/23/2019 |
| Start Date: | December 2008 |
| End Date: | January 2015 |
"2008P-00346: Bone Mass Accrual in Adolescent Athletes"
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.
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.
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.
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.
Inclusion Criteria:
- Female
- 18-21 years of age
- Hypothalamic amenorrhea
- Greater than or equal to 15 years bone age
- BMI between 10th-90th percentiles for age
Exclusion Criteria:
- Use of medications affecting bone metabolism including estrogen/ progesterone,
anabolic steroids and glucocorticoids except local application of glucocorticoid
creams (washout period of three months necessary prior to study enrollment if
medically permissible to discontinue these)
- Presence of anorexia nervosa or %IBW of < 85% based on the 50th %ile of BMI for age
- Spine BMD Z-score < -3
- Conditions other than endurance training that may cause amenorrhea including PCOS
(clinical or preceding laboratory evidence of hyperandrogenism with amenorrhea)
- Conditions other than endurance training that may cause bone metabolism to be affected
- Abnormal TSH, elevated FSH, hematocrit < 30%
- Pregnancy
For girls with AA (to be randomized to estrogen and progesterone or no treatment)
- History of migraines, hypertension, allergy to peanut oil, undiagnosed abnormal
genital bleeding, known, suspected or history of breast or genital cancer or estrogen
dependent neoplasia, known hypersensitivity to progesterone or estrogen or other
product ingredients, liver dysfunction or disease
- LFTs greater than 1.5 times the upper limit of normal
- Family history or personal history of conditions that may increase risk of
thromboembolism:
1. Family history of myocardial infarction or strokes occurring at less than 50
years
2. Family history of clotting disorders: normal coagulation profile will be
necessary for enrollment
- History of smoking >10 cigarettes a day (history of smoking >14 cigarettes a day is a
contraindication for estrogen, but we will be more conservative in our exclusion
criteria)
- Personal history of blood clots
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