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Transdermal Estrogen in Women With Anorexia Nervosa

Primary Purpose

Anorexia Nervosa

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Transdermal estrogen

Placebos

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring Bone mineral density, Estrogen

Eligibility Criteria

19 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Female
19-45 years of age
DSM-5 psychiatric criteria for anorexia nervosa
<85% of ideal body weight as defined by the 1983 Metropolitan Life Insurance Height and Weight Tables
Amenorrhea
T-score of < -1.0 at spine or hip

Exclusion Criteria:

Diseases known to affect bone metabolism, including untreated thyroid dysfunction, vitamin D deficiency, Cushing's syndrome, diabetes mellitus or renal insufficiency (eGFR < 60)
Personal history of venous or arterial clot
History of stroke or myocardial infarction
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 IV bisphosphonates within three years of the baseline visit
Bone fracture within the prior 12 months
Serum potassium < 3.0 meq/L, serum ALT > 3 times the upper limit of normal or Hemoglobin < 10 g/dL
Fasting serum triglyceride level > 150 mg/dL
Pregnant or breastfeeding (or desiring pregnancy within the next 18 months)
Active substance abuse
Elevated PTH level
25-OH vitamin D level < 20 ng/mL
Low phosphorus level

Sites / Locations

University of Pittsburgh School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Transdermal estrogen/progesterone

Placebo

Arm Description

Transdermal estradiol (0.045mg)/levonorgestrel (0.015mg) patch applied weekly for 18 months

Placebo patch applied weekly for 18 months

Outcomes

Primary Outcome Measures

Change in bone mineral density at 18 months

Change in lumbar spine bone mineral density at 18 months

Secondary Outcome Measures

Change in bone mineral density at hip at 18 months

Change in total hip bone mineral density at 18 months

Change in bone mineral density at femoral neck at 18 months

Change in femoral neck bone mineral density at 18 months

Change in parameters of bone microarchitecture at 18 months

Change in microarchitectural parameters as measured by high-resolution peripheral quantitative CT at 18 months

Change in estimated bone strength at 18 months

Change in estimated bone strength as assessed by finite element analysis at 18 months

Change in vertebral fractures at 18 months

Change in vertebral fractures as assessed by vertebral fracture assessment at 18 months

Full Information

NCT ID

NCT03875378

First Posted

March 11, 2019

Last Updated

May 19, 2023

Sponsor

Pouneh K. Fazeli, MD

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

1. Study Identification

Unique Protocol Identification Number

NCT03875378

Brief Title

Transdermal Estrogen in Women With Anorexia Nervosa

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 28, 2020 (Actual)

Primary Completion Date

September 30, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Pouneh K. Fazeli, MD

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

Anorexia nervosa is a prevalent psychiatric with a lifetime prevalence of up to 2.2%. Among the many medical co-morbidities associated with anorexia nervosa, the most common is significant bone loss, which can persist despite weight recovery. Nearly 90% of women with anorexia nervosa have osteopenia and this low bone mass is associated with an increased fracture risk. Nearly 30% of women with anorexia nervosa report a history of a fracture and a prospective study demonstrated a 7-fold increased risk of fracture in women with anorexia nervosa compared to age-matched controls. Because anorexia nervosa 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 anorexia nervosa is of critical importance. This 18-month randomized, placebo-controlled study will investigate in women (ages 20 to 45 years old) with anorexia nervosa whether treatment with transdermal estrogen replacement will increase bone mineral density (BMD).

6. Conditions and Keywords

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

Anorexia Nervosa

Keywords

Bone mineral density, Estrogen

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Randomized, double-blind, placebo-controlled

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Transdermal estrogen/progesterone

Arm Type

Experimental

Arm Description

Transdermal estradiol (0.045mg)/levonorgestrel (0.015mg) patch applied weekly for 18 months

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo patch applied weekly for 18 months

Intervention Type

Drug

Intervention Name(s)

Transdermal estrogen

Intervention Description

Transdermal estradiol (0.045mg)/levonorgestrel (0.015mg) weekly patch

Intervention Type

Drug

Intervention Name(s)

Placebos

Intervention Description

Placebo weekly patch

Primary Outcome Measure Information:

Title

Change in bone mineral density at 18 months

Description

Change in lumbar spine bone mineral density at 18 months

Time Frame

Baseline, 18 months

Secondary Outcome Measure Information:

Title

Change in bone mineral density at hip at 18 months

Description

Change in total hip bone mineral density at 18 months

Time Frame

Baseline, 18 months

Title

Change in bone mineral density at femoral neck at 18 months

Description

Change in femoral neck bone mineral density at 18 months

Time Frame

Baseline, 18 months

Title

Change in parameters of bone microarchitecture at 18 months

Description

Change in microarchitectural parameters as measured by high-resolution peripheral quantitative CT at 18 months

Time Frame

Baseline, 18 months

Title

Change in estimated bone strength at 18 months

Description

Change in estimated bone strength as assessed by finite element analysis at 18 months

Time Frame

Baseline, 18 months

Title

Change in vertebral fractures at 18 months

Description

Change in vertebral fractures as assessed by vertebral fracture assessment at 18 months

Time Frame

Baseline, 18 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female 19-45 years of age DSM-5 psychiatric criteria for anorexia nervosa <85% of ideal body weight as defined by the 1983 Metropolitan Life Insurance Height and Weight Tables Amenorrhea T-score of < -1.0 at spine or hip Exclusion Criteria: Diseases known to affect bone metabolism, including untreated thyroid dysfunction, vitamin D deficiency, Cushing's syndrome, diabetes mellitus or renal insufficiency (eGFR < 60) Personal history of venous or arterial clot History of stroke or myocardial infarction 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 IV bisphosphonates within three years of the baseline visit Bone fracture within the prior 12 months Serum potassium < 3.0 meq/L, serum ALT > 3 times the upper limit of normal or Hemoglobin < 10 g/dL Fasting serum triglyceride level > 150 mg/dL Pregnant or breastfeeding (or desiring pregnancy within the next 18 months) Active substance abuse Elevated PTH level 25-OH vitamin D level < 20 ng/mL Low phosphorus level

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pouneh Fazeli, MD

Phone

412-586-9700

pkfazeli@pitt.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Shari Reynolds

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pouneh Fazeli, MD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pittsburgh School of Medicine

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pouneh K Fazeli, MD

Phone

412-586-9700

pkfazeli@pitt.edu

First Name & Middle Initial & Last Name & Degree

Shari Reynolds

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The final dataset will include self-reported demographic and behavioral data from interviews with the subjects, laboratory data from blood specimens provided and radiologic images of subjects with anorexia nervosa. Because anorexia nervosa is a psychiatric disease and we will be collecting identifying information, even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that the information disclosed by the subjects should be protected in the most stringent way possible in order to prevent possible identification of subjects. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: 1) a commitment to using the data only for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed.

IPD Sharing Time Frame

12 months after publication and no pre-specified end date.

Learn more about this trial

Transdermal Estrogen in Women With Anorexia Nervosa

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