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Bone Mass Accrual in Adolescent Athletes

NCT ID: NCT00827151

Last Updated: 2021-10-26

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

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Amenorrhea Bone Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Estrogen and lifestyle

Group Type ACTIVE_COMPARATOR

Estrogen

Intervention Type DRUG

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

Lifestyle

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Estrogen

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

Intervention Type DRUG

Other Intervention Names

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Vivelle-Dot Prometrium

Eligibility Criteria

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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
* Personal history of blood clots
Minimum Eligible Age

18 Years

Maximum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Madhusmita Misra

Professor Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Madhu Misra, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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NIH-HCNRC

Identifier Type: -

Identifier Source: secondary_id

2008P00246

Identifier Type: -

Identifier Source: org_study_id