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

August 31, 2020 updated by: Karen Klahr Miller, MD, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

community sample and referrals by specialists

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Karen K Miller, MD, Massachusetts General Hospital
  • Principal Investigator: Anne A Klibanski, 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

November 7, 2007

First Submitted That Met QC Criteria

November 7, 2007

First Posted (Estimate)

November 9, 2007

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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