Transdermal Estrogen in Women With Anorexia Nervosa
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transdermal estrogen, Placebos.
- Who it may be relevant to
- Registry conditions: Anorexia Nervosa. Basic parameters: 19 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transdermal Estrogen for the Treatment of Bone Loss in Women With Anorexia Nervosa
Overview
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).
Interventions
- Drug Transdermal estrogen
Transdermal estradiol (0.045mg)/levonorgestrel (0.015mg) weekly patch - Drug Placebos
Placebo weekly patch
Primary outcome measures
- Change in bone mineral density at 18 months [Time frame: Baseline, 18 months]
Secondary outcome measures (5)
- Change in bone mineral density at hip at 18 months [Time frame: Baseline, 18 months]
- Change in bone mineral density at femoral neck at 18 months [Time frame: Baseline, 18 months]
- Change in parameters of bone microarchitecture at 18 months [Time frame: Baseline, 18 months]
- Change in estimated bone strength at 18 months [Time frame: Baseline, 18 months]
- Change in vertebral fractures at 18 months [Time frame: Baseline, 18 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Pittsburgh School of Medicine — Pittsburgh
Identifiers
NCT: NCT03875378 · STUDY19070395 · R01HD099139