NCT00827151

Bone Mass Accrual in Adolescent Athletes

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 21 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Amenorrhea
• Bone Loss

Interventions

Type	Name	Description
DRUG	Estrogen	Estrogen 100 mcg patch twice weekly with 10 days of oral progesterone monthly for 12 months versus no medication

Timeline

• Start date: 2008-12-01
• Primary completion: 2011-05-01
• Completion: 2015-01-01
• First posted: 2009-01-22
• Last updated: 2021-10-26

Locations

1 site across 1 country: United States