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

NCT ID: NCT00556036

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anorexia Nervosa Hypothalamic Amenorrhea Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

lean healthy women, age 18-45

No interventions assigned to this group

2

overweight healthy women, age 18-45

No interventions assigned to this group

3

women with hypothalamic amenorrhea (have not had a period in three months), age 18-45

No interventions assigned to this group

4

women with anorexia nervosa, age 18-45

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Bioenvision

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karen Klahr Miller, MD

Chief, Neuroendocrine Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne A Klibanski, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Karen K Miller, MD

Role: STUDY_DIRECTOR

Massachusetts General Hospital

Erinne M Meenaghan, NP

Role: STUDY_CHAIR

Massachusetts General Hospital

Elizabeth A Lawson, MD

Role: STUDY_DIRECTOR

Massachusetts General Hospital

David B Herzog, MD

Role: STUDY_CHAIR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2003p-000549

Identifier Type: -

Identifier Source: org_study_id

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