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Hormone Dynamics and Bone Mineral Density in Anorexia Nervosa v. Hypothalamic Amenorrhea

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ClinicalTrials.gov Identifier: NCT00556036
Recruitment Status : Completed
First Posted : November 9, 2007
Last Update Posted : December 19, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine whether the hormone dynamics in women with anorexia nervosa and hypothalamic amenorrhea is related to bone loss in those populations.

Condition or disease
Anorexia Nervosa Hypothalamic Amenorrhea Obesity

Study Design

Study Type : Observational
Actual Enrollment : 61 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Hormone Dynamics and Bone Mineral Density in Anorexia Nervosa v. Hypothalamic Amenorrhea
Study Start Date : March 2006
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

lean healthy women, age 18-45
overweight healthy women, age 18-45
women with hypothalamic amenorrhea (have not had a period in three months), age 18-45
women with anorexia nervosa, age 18-45

Outcome Measures

Biospecimen Retention:   Samples Without DNA
whole blood, serum, urine, saliva, optional DNA substudy.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
community sample and referrals by specialists

Inclusion Criteria:

  • Amenorrhea for at least three months (unless participating as healthy control)
  • Normal TSH or free thyroxine (free T4).

Exclusion Criteria:

  • A condition known to affect bone metabolism, including Cushing's syndrome or renal failure, with the exception of bone fracture.
  • Any medication known to affect bone metabolism within 3 months of the study, including estrogen and progestins. Patients receiving depot medroxyprogesterone (Depo-Provera) will be excluded from participating for 6 months after their last injection.
  • Pregnant and/or breastfeeding.
  • Diabetes mellitus.
  • Active substance abuse, including alcohol.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00556036

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
Principal Investigator: Anne A Klibanski, MD Massachusetts General Hospital
Study Director: Karen K Miller, MD Massachusetts General Hospital
Study Chair: Erinne M Meenaghan, NP Massachusetts General Hospital
Study Director: Elizabeth A Lawson, MD Massachusetts General Hospital
Study Chair: David B Herzog, MD Massachusetts General Hospital
More Information

Responsible Party: Anne Klibanski, MD, Chief, Neuroendocrine Unit, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00556036     History of Changes
Other Study ID Numbers: 2003p-000549
First Posted: November 9, 2007    Key Record Dates
Last Update Posted: December 19, 2011
Last Verified: December 2011

Keywords provided by Anne Klibanski, MD, Massachusetts General Hospital:
anorexia nervosa
bone density

Additional relevant MeSH terms:
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Menstruation Disturbances
Pathologic Processes
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs