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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00556036
Collaborator
National Institutes of Health (NIH) (NIH), Bioenvision (Industry)
61
Enrollment
1
Location
36
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    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 :
    Mar 1, 2006
    Actual Primary Completion Date :
    Mar 1, 2009
    Actual Study Completion Date :
    Mar 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 45 Years
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Karen Klahr Miller, MD, Chief, Neuroendocrine Unit, Massachusetts General Hospital
      ClinicalTrials.gov Identifier:
      NCT00556036
      Other Study ID Numbers:
      • 2003p-000549
      First Posted:
      Nov 9, 2007
      Last Update Posted:
      Sep 2, 2020
      Last Verified:
      Aug 1, 2020
      Keywords provided by Karen Klahr Miller, MD, Chief, Neuroendocrine Unit, 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:
      Anorexia
      Amenorrhea
      Anorexia Nervosa

      Study Results

      No Results Posted as of Sep 2, 2020