Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa

• Status: Completed
• Trial end date: 2018-07-30
• Target enrollment: 0
• Participant gender: Female

Summary

Decreased bone strength is a common and serious medical problem present in many women with anorexia nervosa. Women with decreased bone strength are more likely to suffer broken bones than women with normal bone strength.

This study will investigate whether the use of transdermal estrogen can improve bone mineral density (BMD) and bone microarchitecture in women with anorexia nervosa anorexia nervosa when used for 6 months.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Levonorgestrel; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Female; ages 25-50 years

• Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) psychiatric criteria for AN, including <85% of ideal body weight as defined by the 1983 Metropolitan Life Insurance Height and Weight Tables, and amenorrhea

• T-score of < -1.5 at spine or hip

• Treatment team or treatment professional in place for clinical treatment/monitoring during the study

Exclusion Criteria:

• Diseases known to affect bone metabolism, including untreated thyroid dysfunction, vitamin D deficiency, Cushing's syndrome, diabetes mellitus or renal insufficiency

• Personal history of venous or arterial clot

• History of stroke or myocardial infarction

• History of migraine headaches

• 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 intravenous (IV) bisphosphonates within three years of the baseline visit

• Bone fracture within the prior 12 months

• Serum potassium < 3.0 meq/L or serum alanine aminotransferase (ALT) > 3 times the upper limit of normal

• Fasting serum triglyceride level > 150 mg/dL

• Pregnant or breastfeeding

• Active substance abuse