Bone Mass Accrual in Adolescent Athletes (838)

This study has been withdrawn prior to enrollment.
(The study was not funded)
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00827151
First received: January 16, 2009
Last updated: May 11, 2011
Last verified: May 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Massachusetts General Hospital:

Primary Outcome Measures:
  • Bone density [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 132
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 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

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

Ages Eligible for Study:   18 Years to 21 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Madhusmita Misra, M.D., Neuroendcrine Unit Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00827151     History of Changes
Other Study ID Numbers: 2008P00246, NIH-HCNRC
Study First Received: January 16, 2009
Last Updated: May 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014