Using transdermal estrogen to improve bone health in women with anorexia nervosa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled study aims to evaluate the effectiveness of transdermal estrogen in increasing bone mineral density (BMD) in adult women aged 20 to 45 with anorexia nervosa. Anorexia nervosa is associated with significant bone loss, leading to increased fracture risk, and this study seeks to address the chronic bone health issues faced by these patients. Participants will receive either transdermal estrogen or a placebo over an 18-month period, with the primary outcome being changes in BMD. The study is crucial for developing effective treatments for the long-term complications of anorexia nervosa.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion Criteria:

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

Where it's running

• University of Pittsburgh School of Medicine
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Pouneh Fazeli, MD — University of Pittsburgh
• Study coordinator: Pouneh Fazeli, MD
• Email: pkfazeli@pitt.edu
• Phone: 412-586-9700

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Narrative medicine workshops to support teens and young adults with anorexia nervosa (virtual)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.