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Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa (1180)

Primary Purpose

Anorexia Nervosa, Osteoporosis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

estradiol 0.045 mg/levonorgestrel 0.015mg

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Anorexia Nervosa, Osteoporosis, Eating Disorder, Disordered Eating, Estrogen, Bone

Eligibility Criteria

25 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

estradiol 0.045mg/levonorgestrel 0.015mg

Arm Description

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

Outcomes

Primary Outcome Measures

Percent Change in Bone Mineral Density (BMD) of Lumbar Spine by Dual Energy X-ray Absorptiometry (DXA)

Percent change in lumbar spine bone mineral density after six-months. Lumbar spine bone mineral density measured by dual energy x-ray absorptiometry.

Secondary Outcome Measures

Full Information

NCT ID

NCT02475265

First Posted

June 10, 2015

Last Updated

July 15, 2019

Sponsor

Massachusetts General Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02475265

Brief Title

Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa

Acronym

1180

Official Title

Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

July 2015 (Actual)

Primary Completion Date

June 27, 2018 (Actual)

Study Completion Date

July 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anorexia Nervosa, Osteoporosis

Keywords

Anorexia Nervosa, Osteoporosis, Eating Disorder, Disordered Eating, Estrogen, Bone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

estradiol 0.045mg/levonorgestrel 0.015mg

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

estradiol 0.045 mg/levonorgestrel 0.015mg

Other Intervention Name(s)

Climara Pro transdermal patch

Primary Outcome Measure Information:

Title

Percent Change in Bone Mineral Density (BMD) of Lumbar Spine by Dual Energy X-ray Absorptiometry (DXA)

Description

Percent change in lumbar spine bone mineral density after six-months. Lumbar spine bone mineral density measured by dual energy x-ray absorptiometry.

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pouneh K Fazeli, MD

Organizational Affiliation

MGH/Harvard Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

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Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa

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