Hormone Dynamics and Bone Mineral Density in Anorexia Nervosa v. Hypothalamic Amenorrhea - Full Text View

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

This study is currently recruiting participants.
Verified by Massachusetts General Hospital, November 2007

Sponsors and Collaborators:	Massachusetts General Hospital National Institutes of Health (NIH) Bioenvision
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00556036

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

MedlinePlus related topics:

Minerals Obesity

ChemIDplus related topics:

Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Cross-Sectional

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

Further study details as provided by Massachusetts General Hospital:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

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

Estimated Enrollment:	120
Study Start Date:	March 2006
Estimated Study Completion Date:	December 2008

Groups/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

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

Contacts


Contact: Janet A Lydecker, BA	617-724-1838	jlydecker@partners.org

Contact: Erinne M Meenaghan, NP	617-724-5656	emeenaghan@partners.org

Locations


United States, Massachusetts
	Massachusetts General Hospital	Recruiting
	Boston, Massachusetts, United States, 02114
	Principal Investigator: Anne A Klibanski, MD

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

Study ID Numbers:	2003p-000549
First Received:	November 7, 2007
Last Updated:	November 7, 2007
ClinicalTrials.gov Identifier:	NCT00556036
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

Study placed in the following topic categories:

Obesity

Hydrocortisone

Depression

Cortisol succinate

Signs and Symptoms, Digestive

Amenorrhea

Osteoporosis

Stress

Overweight

Healthy

Depressive Disorder

Body Weight

Signs and Symptoms

Menstruation Disturbances

Mental Disorders

Anorexia

Nutrition Disorders

Overnutrition

Hydrocortisone acetate

Anorexia Nervosa

Eating Disorders

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2008