RECRUITING

Transdermal Estrogen in Women with Anorexia Nervosa

Conditions

Anorexia Nervosa Bone mineral density Estrogen

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2020-08-28

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03875378

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.

Ages Eligible for Study:19 Years to 45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Pouneh Fazeli, MD

CONTACT

412-586-9700

pkfazeli@pitt.edu

Shari Reynolds

CONTACT

Principal Investigator

Pouneh Fazeli, MD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: Pouneh K. Fazeli, MD

Pouneh Fazeli, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-28

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2020-08-28

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

Bone mineral density
Estrogen

Additional Relevant MeSH Terms

Anorexia Nervosa