Bone Mass Accrual in Adolescent Athletes - Full Text View

Sponsored by:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00827151

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	"2008P-00346: Bone Mass Accrual in Adolescent Athletes"

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:	December 2012
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Estrogen and lifestyle: Active Comparator	Drug: Estrogen Estrogen 100 mcg patch twice weekly with 10 days of oral progesterone monthly for 12 months versus no medication
Lifestyle: No Intervention	Drug: Estrogen Estrogen 100 mcg patch twice weekly with 10 days of oral progesterone monthly for 12 months versus no medication

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827151

Contacts

Contact: Nara Mendes	617 724 6046	nmendes1@partners.org
Contact: Jenna Stark	617 726 8201	jnstark@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Madhu Misra, M.D. 617-724-5602 mmisra@partners.org
Principal Investigator: Madhu Misra, M.D.

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Madhu Misra, MD, MPH

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Neuroendcrine Unit Massachusetts General Hospital ( Madhusmita Misra, M.D. )
Study ID Numbers:	2008P00246, NIH-HCNRC
Study First Received:	January 16, 2009
Last Updated:	July 22, 2009
ClinicalTrials.gov Identifier:	NCT00827151 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:

amenorrhea
athletes
bone loss
eumenorrhea

Study placed in the following topic categories:

Estrogens
Progesterone
Menstruation Disturbances
Hormone Antagonists
Estradiol 3-benzoate
Estradiol valerate

Hormones, Hormone Substitutes, and Hormone Antagonists
Amenorrhea
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Hormones
Estradiol

Additional relevant MeSH terms:

Estrogens
Pathologic Processes
Menstruation Disturbances
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Amenorrhea
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009