Bone Mass Accrual in Adolescent Athletes (838)

October 22, 2021 updated by: Madhusmita Misra, Massachusetts General Hospital

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 21 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Prometrium
  • Vivelle-Dot
No Intervention: Lifestyle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bone density
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Madhu Misra, MD, MPH, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

January 16, 2009

First Submitted That Met QC Criteria

January 20, 2009

First Posted (Estimate)

January 22, 2009

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 22, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008P00246
  • NIH-HCNRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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