Bone Mass Accrual in Adolescent Athletes

NCT00827151 | Withdrawn Phase 3 DMC

• 2 other identifiers: 2008P00246NIH-HCNRC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Amenorrhea; Bone Loss

Keywords

amenorrhea; athletes; bone loss; eumenorrhea

Outcome Measures

Primary Outcomes (1)

• Bone density

  One year

Study Arms (2)

Estrogen and lifestyle

ACTIVE COMPARATOR

Drug: Estrogen

Lifestyle

NO INTERVENTION

Interventions

Estrogen DRUG

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

Also known as: Vivelle-Dot, Prometrium

Estrogen and lifestyle

Eligibility Criteria

• Age: 18 Years - 21 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• years of age
• Hypothalamic amenorrhea
• Greater than or equal to 15 years bone age
• BMI between 10th-90th percentiles for age

You may not qualify if:

• 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:
• Family history of myocardial infarction or strokes occurring at less than 50 years
• Family history of clotting disorders: normal coagulation profile will be necessary for enrollment
• Personal history of blood clots

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Amenorrhea; Bone Diseases, Metabolic

Interventions

Estrogens; Estradiol; Progesterone

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Pregnenediones; Pregnenes; Pregnanes; Corpus Luteum Hormones; Progesterone Congeners

Study Officials

• Madhu Misra, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Pediatrics

Study Record Dates

• First Submitted: January 16, 2009
• First Posted: January 22, 2009
• Study Start: December 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: January 1, 2015
• Last Updated: October 26, 2021

Record last verified: 2021-10

Locations

US (1)