Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa (1180)
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|ClinicalTrials.gov Identifier: NCT02475265|
Recruitment Status : Completed
First Posted : June 18, 2015
Results First Posted : July 22, 2019
Last Update Posted : July 22, 2019
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
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
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Pouneh K Fazeli, MD||MGH/Harvard Medical School|