Expired Study
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Boston, Massachusetts 02114


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

2008P00246


NCT ID:

NCT00827151


Secondary ID:

NIH-HCNRC


Study Acronym:

838


Brief Title:

Bone Mass Accrual in Adolescent Athletes


Official Title:

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


Overall Status:

Withdrawn


Study Phase:

Phase 3


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

21 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Massachusetts General Hospital


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

The study was not funded


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Madhu Misra, MD, MPH
Principal Investigator
Massachusetts General Hospital

Study Dates

Start Date:December 2008
Completion Date:January 2015
Completion Type:Anticipated
Primary Completion Date:May 2011
Primary Completion Type:Actual
Verification Date:February 2019
Last Changed Date:February 19, 2019
First Received Date:January 16, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:Bone density
Time Frame:One year
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Estrogen
Description:Estrogen 100 mcg patch twice weekly with 10 days of oral progesterone monthly for 12 months versus no medication
Arm Name:Estrogen and lifestyle
Other Name:Vivelle-Dot

Study Arms

Study Arm Type:No Intervention
Arm Name:Lifestyle
Study Arm Type:Active Comparator
Arm Name:Estrogen and lifestyle

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Massachusetts General Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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