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Bone Mass Accrual in Adolescent Athletes (838)

This study has been withdrawn prior to enrollment.
(The study was not funded)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00827151
First Posted: January 22, 2009
Last Update Posted: September 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Madhusmita Misra, Massachusetts General Hospital
  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.

Condition Intervention Phase
Amenorrhea Bone Loss Drug: Estrogen Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "2008P-00346: Bone Mass Accrual in Adolescent Athletes"

Resource links provided by NLM:


Further study details as provided by Madhusmita Misra, Massachusetts General Hospital:

Primary Outcome Measures:
  • Bone density [ Time Frame: One year ]

Enrollment: 0
Study Start Date: December 2008
Estimated Study Completion Date: January 2015
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 21 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00827151


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Madhu Misra, MD, MPH Massachusetts General Hospital
  More Information

Responsible Party: Madhusmita Misra, Professor Pediatrics, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00827151     History of Changes
Other Study ID Numbers: 2008P00246
NIH-HCNRC
First Submitted: January 16, 2009
First Posted: January 22, 2009
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by Madhusmita Misra, Massachusetts General Hospital:
amenorrhea
athletes
bone loss
eumenorrhea

Additional relevant MeSH terms:
Amenorrhea
Menstruation Disturbances
Pathologic Processes
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs


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