Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa

NCT ID: NCT02475265

Last Updated: 2019-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2018-07-30

Brief 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.

Detailed Description

Anorexia nervosa (AN) is a prevalent psychiatric disorder affecting up to 1% of college-aged women in the US and an increasing number of women over 30 years of age. Among the many medical co-morbidities associated with AN, the most common is significant bone loss, which can persist despite weight recovery. Nearly 50% of women with AN have osteopenia with an additional 30% meeting WHO criteria for osteoporosis. Importantly, this severe bone loss is associated with an increased fracture risk. Nearly 30% of women with AN report a history of a fracture and a prospective study demonstrated a 7-fold increased risk of fracture in women with AN compared to age-matched controls. Because AN is a chronic disease that can persist despite psychiatric and nutritional counseling, the bone loss and increased fracture risk can persist and lead to lifelong morbidity. Therefore, finding a treatment for bone loss associated with AN is of critical importance.

This 6 month open-label study will investigate in women (ages 25 to 50 years old) with AN whether treatment with transdermal estrogen replacement will increase bone mineral density (BMD), improve parameters of bone microarchitecture as assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT), and improve bone strength as estimated by microfinite element analysis.

Conditions

Anorexia Nervosa; Osteoporosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

estradiol 0.045mg/levonorgestrel 0.015mg

6 months of estradiol 0.045mg/levonorgestrel 0.015mg (once weekly patch).

Group Type: EXPERIMENTAL

estradiol 0.045 mg/levonorgestrel 0.015mg

Intervention Type: DRUG

Interventions

estradiol 0.045 mg/levonorgestrel 0.015mg

Intervention Type: DRUG

Other Intervention Names

Climara Pro transdermal patch

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Pouneh K. Fazeli, MD

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pouneh K Fazeli, MD

Role: PRINCIPAL_INVESTIGATOR

MGH/Harvard Medical School

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R03DK106410

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2015P000463

Identifier Type: -

Identifier Source: org_study_id