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

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Mass General Brigham

Status

Completed

Conditions

Obesity
Anorexia Nervosa
Hypothalamic Amenorrhea

Study type

Observational

Funder types

Other
Industry
NIH

Identifiers

NCT00556036
2003p-000549

Details and patient eligibility

About

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.

Enrollment

61 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

61 participants in 4 patient groups

1
Description:
lean healthy women, age 18-45
2
Description:
overweight healthy women, age 18-45
3
Description:
women with hypothalamic amenorrhea (have not had a period in three months), age 18-45
4
Description:
women with anorexia nervosa, age 18-45

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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