Clinical Trial: Bone Mass Accrual in Adolescent Athletes

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

Brief Summary: 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 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.
Sponsor: Massachusetts General Hospital

Current Primary Outcome: Bone density [ Time Frame: One year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Massachusetts General Hospital

Dates:
Date Received: January 16, 2009
Date Started: December 2008
Date Completion: January 2015
Last Updated: September 21, 2015
Last Verified: September 2015