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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02475265
Recruitment Status : Completed
First Posted : June 18, 2015
Results First Posted : July 22, 2019
Last Update Posted : July 22, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Pouneh K. Fazeli, MD, Massachusetts General Hospital

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.


Condition or disease Intervention/treatment Phase
Anorexia Nervosa Osteoporosis Drug: estradiol 0.045 mg/levonorgestrel 0.015mg Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa
Actual Study Start Date : July 2015
Actual Primary Completion Date : June 27, 2018
Actual Study Completion Date : July 30, 2018


Arm Intervention/treatment
Experimental: estradiol 0.045mg/levonorgestrel 0.015mg
6 months of estradiol 0.045mg/levonorgestrel 0.015mg (once weekly patch).
Drug: estradiol 0.045 mg/levonorgestrel 0.015mg
Other Name: Climara Pro transdermal patch




Primary Outcome Measures :
  1. Percent Change in Bone Mineral Density (BMD) of Lumbar Spine by Dual Energy X-ray Absorptiometry (DXA) [ Time Frame: 6 months ]
    Percent change in lumbar spine bone mineral density after six-months. Lumbar spine bone mineral density measured by dual energy x-ray absorptiometry.



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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475265


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Pouneh K Fazeli, MD MGH/Harvard Medical School
  Study Documents (Full-Text)

Documents provided by Pouneh K. Fazeli, MD, Massachusetts General Hospital:
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Responsible Party: Pouneh K. Fazeli, MD, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02475265    
Other Study ID Numbers: 2015P000463
R03DK106410 ( U.S. NIH Grant/Contract )
First Posted: June 18, 2015    Key Record Dates
Results First Posted: July 22, 2019
Last Update Posted: July 22, 2019
Last Verified: July 2019
Keywords provided by Pouneh K. Fazeli, MD, Massachusetts General Hospital:
Anorexia Nervosa
Osteoporosis
Eating Disorder
Disordered Eating
Estrogen
Bone
Additional relevant MeSH terms:
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Osteoporosis
Anorexia
Anorexia Nervosa
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders
Levonorgestrel
Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral