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Effects of Anorexia Nervosa on Bone Mass in Adolescents

NCT00088153 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2021-11-02

Study results available
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Summary

This study is to determine the effects of anorexia nervosa on bone mass and hormone levels in adolescents. Whether administration of estrogen, a normal hormone present during puberty, can help maintain bone development in girls with anorexia nervosa will be determined.

Conditions

  • Anorexia Nervosa

Interventions

DRUG

Physiologic Estrogen/progesterone

Vivelle Dot patch 100 mcg twice weekly; Provera 2.5 mg daily for the first 10 days of the month

OTHER

Placebo

Placebo patches twice weekly; Placebo pills daily for the first 10 days of every month

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • The Hospital for Sick Children

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Madhusmita Misra, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2011-02-28
Completion
2011-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00088153 on ClinicalTrials.gov