Transdermal Estrogen in Women with Anorexia Nervosa

Description

Randomized, placebo-controlled study investigating the use of physiologic, transdermal estrogen for low bone mass in adult women with anorexia nervosa.

Conditions

Anorexia Nervosa

Study Overview

Study Details

Study overview

Randomized, placebo-controlled study investigating the use of physiologic, transdermal estrogen for low bone mass in adult women with anorexia nervosa.

Transdermal Estrogen for the Treatment of Bone Loss in Women with Anorexia Nervosa

Transdermal Estrogen in Women with Anorexia Nervosa

Condition
Anorexia Nervosa
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, United States, 15213

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Female
  • 2. 19-45 years of age
  • 3. DSM-5 psychiatric criteria for anorexia nervosa
  • 4. \<85% of ideal body weight as defined by the 1983 Metropolitan Life Insurance Height and Weight Tables
  • 5. Amenorrhea
  • 6. T-score of \< -1.0 at spine or hip
  • 1. Diseases known to affect bone metabolism, including untreated thyroid dysfunction, vitamin D deficiency, Cushing's syndrome, diabetes mellitus or renal insufficiency (eGFR \< 60)
  • 2. Personal history of venous or arterial clot
  • 3. History of stroke or myocardial infarction
  • 4. History of hypercoagulable disorder
  • 5. Personal history or history of a first-degree relative with breast cancer
  • 6. History of hereditary angioedema
  • 7. Any medication known to affect bone metabolism, including systemic glucocorticoids within three months of the baseline visit, depot medroxyprogesterone within 6 months of the baseline visit, oral bisphosphonates within one year of the baseline visit or IV bisphosphonates within three years of the baseline visit
  • 8. Bone fracture within the prior 12 months
  • 9. Serum potassium \< 3.0 meq/L, serum ALT \> 3 times the upper limit of normal or Hemoglobin \< 10 g/dL
  • 10. Fasting serum triglyceride level \> 150 mg/dL
  • 11. Pregnant or breastfeeding (or desiring pregnancy within the next 18 months)
  • 12. Active substance abuse
  • 13. Elevated PTH level
  • 14. 25-OH vitamin D level \< 20 ng/mL
  • 15. Low phosphorus level

Ages Eligible for Study

19 Years to 45 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pouneh K. Fazeli, MD,

Pouneh Fazeli, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2025-12-31