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NCT00556036 Clinical Trial

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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00556036
Other study ID # 2003p-000549
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2006
Est. completion date March 2009

Study information
Verified date August 2020
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 61
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (3)
Lead Sponsor Collaborator
Massachusetts General Hospital Bioenvision, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

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