Transdermal Estrogen for the Treatment of Bone Loss in Women With Anorexia Nervosa
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Change in bone mineral density at 18 months
研究概览
简要总结
Randomized, placebo-controlled study investigating the use of physiologic, transdermal estrogen for low bone mass in adult women with anorexia nervosa.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •T-score of < -1.0 at spine or hip
排除标准
- •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
研究组 & 干预措施
Placebo
Placebo patch applied weekly for 18 months
干预措施: Placebos (Drug)
Transdermal estrogen/progesterone
Transdermal estradiol (0.045mg)/levonorgestrel (0.015mg) patch applied weekly for 18 months
干预措施: Transdermal estrogen (Drug)
结局指标
主要结局
Change in bone mineral density at 18 months
时间窗: Baseline, 18 months
Change in lumbar spine bone mineral density at 18 months
次要结局
- Change in bone mineral density at hip at 18 months(Baseline, 18 months)
- Change in bone mineral density at femoral neck at 18 months(Baseline, 18 months)
- Change in parameters of bone microarchitecture at 18 months(Baseline, 18 months)
- Change in estimated bone strength at 18 months(Baseline, 18 months)
- Change in vertebral fractures at 18 months(Baseline, 18 months)
研究者
Pouneh K. Fazeli, MD
Associate Professor of Medicine
University of Pittsburgh