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

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Bioenvision
Information provided by (Responsible Party):
Anne Klibanski, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00556036
First received: November 7, 2007
Last updated: December 15, 2011
Last verified: December 2011
History of Changes
  Purpose

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
Anorexia Nervosa
Hypothalamic Amenorrhea
Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Hormone Dynamics and Bone Mineral Density in Anorexia Nervosa v. Hypothalamic Amenorrhea

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Biospecimen Retention:   Samples Without DNA

whole blood, serum, urine, saliva, optional DNA substudy.


Enrollment: 61
Study Start Date: March 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
lean healthy women, age 18-45
2
overweight healthy women, age 18-45
3
women with hypothalamic amenorrhea (have not had a period in three months), age 18-45
4
women with anorexia nervosa, age 18-45

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

community sample and referrals by specialists

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556036

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
Bioenvision
Investigators
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

No publications provided

Responsible Party: Anne Klibanski, MD, Chief, Neuroendocrine Unit, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00556036     History of Changes
Other Study ID Numbers: 2003p-000549
Study First Received: November 7, 2007
Last Updated: December 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
healthy
overweight
obese
anorexia nervosa
weight
cortisol
hormone
bone density
bone
 osteopenia
osteoporosis
amenorrhea
menses
irregular
stress
depression
exercise
diet

Additional relevant MeSH terms:
Amenorrhea
Anorexia
Anorexia Nervosa
Obesity
Menstruation Disturbances
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
 Mental Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013