drugset / Trial / NCT00827151

Bone Mass Accrual in Adolescent Athletes

NCT00827151

Phase 3 Withdrawn Massachusetts General Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2008-12
Primary completion
2011-05
Completion
2015-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Progesterone Other / unclassified Oral
Comparator conjugated estrogens Other / unclassified 0.1 mg Other

Indications