RecruitingPhase 2NCT03875378

Transdermal Estrogen in Women With Anorexia Nervosa

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

Sponsor

Pouneh K. Fazeli, MD

Enrollment

66 participants

Start Date

Aug 28, 2020

Study Type

INTERVENTIONAL

Conditions

Anorexia Nervosa

Summary

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

Eligibility

Sex: FEMALEMin Age: 19 YearsMax Age: 45 Years

Inclusion Criteria6

Female
19-45 years of age
DSM-5 psychiatric criteria for anorexia nervosa
<85% of ideal body weight as defined by the 1983 Metropolitan Life Insurance Height and Weight Tables
Amenorrhea
T-score of < -1.0 at spine or hip

Exclusion Criteria15

Diseases known to affect bone metabolism, including untreated thyroid dysfunction, vitamin D deficiency, Cushing's syndrome, diabetes mellitus or renal insufficiency (eGFR < 60)
Personal history of venous or arterial clot
History of stroke or myocardial infarction
History of hypercoagulable disorder
Personal history or history of a first-degree relative with breast cancer
History of hereditary angioedema
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
Bone fracture within the prior 12 months
Serum potassium < 3.0 meq/L, serum ALT > 3 times the upper limit of normal or Hemoglobin < 10 g/dL
Fasting serum triglyceride level > 150 mg/dL
Pregnant or breastfeeding (or desiring pregnancy within the next 18 months)
Active substance abuse
Elevated PTH level
25-OH vitamin D level < 20 ng/mL
Low phosphorus level