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

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

This study is testing if a skin patch with estrogen can help improve bone health in women aged 20 to 45 who have anorexia nervosa.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 19 Years to 45 Years
• Sex: Female
• Sponsor: University of Pittsburgh (Academic / other)
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT03875378 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are women aged 19 to 45 with a diagnosis of anorexia nervosa, low body weight, amenorrhea, and low bone mineral density.

Not a fit: Patients with conditions affecting bone metabolism or a history of certain medical issues, such as clotting disorders or breast cancer, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve bone health and reduce fracture risk in women suffering from anorexia nervosa.

How similar studies have performed: While there is limited research specifically on transdermal estrogen for this population, studies on estrogen's role in bone health suggest potential benefits, making this approach promising yet somewhat novel.

Eligibility criteria

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 this trial is running

Pittsburgh, Pennsylvania

• 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

Conditions Anorexia Nervosa; Bone mineral density; Estrogen