- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03875378
Transdermal Estrogen in Women With Anorexia Nervosa
Transdermal Estrogen for the Treatment of Bone Loss in Women With Anorexia Nervosa
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Pouneh Fazeli, MD
- Phone Number: 412-586-9700
- Email: pkfazeli@pitt.edu
Study Contact Backup
- Name: Shari Reynolds
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- University of Pittsburgh School of Medicine
-
Contact:
- Shari Reynolds
-
Contact:
- Pouneh K Fazeli, MD
- Phone Number: 412-586-9700
- Email: pkfazeli@pitt.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transdermal estrogen/progesterone
Transdermal estradiol (0.045mg)/levonorgestrel (0.015mg) patch applied weekly for 18 months
|
Transdermal estradiol (0.045mg)/levonorgestrel (0.015mg) weekly patch
|
Placebo Comparator: Placebo
Placebo patch applied weekly for 18 months
|
Placebo weekly patch
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in bone mineral density at 18 months
Time Frame: Baseline, 18 months
|
Change in lumbar spine bone mineral density at 18 months
|
Baseline, 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in bone mineral density at hip at 18 months
Time Frame: Baseline, 18 months
|
Change in total hip bone mineral density at 18 months
|
Baseline, 18 months
|
Change in bone mineral density at femoral neck at 18 months
Time Frame: Baseline, 18 months
|
Change in femoral neck bone mineral density at 18 months
|
Baseline, 18 months
|
Change in parameters of bone microarchitecture at 18 months
Time Frame: Baseline, 18 months
|
Change in microarchitectural parameters as measured by high-resolution peripheral quantitative CT at 18 months
|
Baseline, 18 months
|
Change in estimated bone strength at 18 months
Time Frame: Baseline, 18 months
|
Change in estimated bone strength as assessed by finite element analysis at 18 months
|
Baseline, 18 months
|
Change in vertebral fractures at 18 months
Time Frame: Baseline, 18 months
|
Change in vertebral fractures as assessed by vertebral fracture assessment at 18 months
|
Baseline, 18 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Pouneh Fazeli, MD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY19070395
- R01HD099139 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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