838: Bone Mass Accrual in Adolescent Athletes

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00827151

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Amenorrhea Bone Loss	Drug: Estrogen	Phase 3

Detailed 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

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

"2008P-00346: Bone Mass Accrual in Adolescent Athletes"

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

May 1, 2011

Anticipated Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Estrogen and lifestyle	Drug: Estrogen Estrogen 100 mcg patch twice weekly with 10 days of oral progesterone monthly for 12 months versus no medication Other Names: Vivelle-Dot Prometrium
No Intervention: Lifestyle

Arm

Intervention/Treatment

Active Comparator: Estrogen and lifestyle

Drug: Estrogen

Estrogen 100 mcg patch twice weekly with 10 days of oral progesterone monthly for 12 months versus no medication

Other Names:

Vivelle-Dot

Prometrium

No Intervention: Lifestyle

Outcome Measures

Primary Outcome Measures

Bone density [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 21 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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:

Family history of myocardial infarction or strokes occurring at less than 50 years
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