- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00556036
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
Conditions
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
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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-
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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2003p-000549
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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