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

NCT00556036 | Completed DMC

• 1 other identifier: 2003p-000549
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa; Hypothalamic Amenorrhea; Obesity

Keywords

healthy; overweight; obese; anorexia nervosa; weight; cortisol; hormone; bone density; bone; osteopenia; osteoporosis; amenorrhea; menses; irregular; stress; depression; exercise; diet

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

community sample and referrals by specialists

You may qualify if:

• Amenorrhea for at least three months (unless participating as healthy control)
• Normal TSH or free thyroxine (free T4).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator
• Bioenvision: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, serum, urine, saliva, optional DNA substudy.

MeSH Terms

Conditions

Anorexia Nervosa; Obesity; Overweight; Body Weight; Bone Diseases, Metabolic; Osteoporosis; Amenorrhea; Depression; Motor Activity

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Menstruation Disturbances; Pathologic Processes; Behavioral Symptoms; Behavior

Study Officials

• Anne A Klibanski, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Karen K Miller, MD

  Massachusetts General Hospital

  STUDY DIRECTOR

• Erinne M Meenaghan, NP

  Massachusetts General Hospital

  STUDY CHAIR

• Elizabeth A Lawson, MD

  Massachusetts General Hospital

  STUDY DIRECTOR

• David B Herzog, MD

  Massachusetts General Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Neuroendocrine Unit

Study Record Dates

• First Submitted: November 7, 2007
• First Posted: November 9, 2007
• Study Start: March 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

US (1)