NCT01100567已完成不适用
EFFECT OF BIOMECHANICAL STIMULATION ON SKELETAL HEALTH IN ADOLESCENT AND YOUNG WOMEN WITH ANOREXIA NERVOSA
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Change From Baseline in C-telopeptides
研究概览
简要总结
This study will evaluate the effects of a novel, non-pharmacologic intervention for the prevention of deleterious changes in bone density and strength in adolescents with anorexia nervosa (AN), a disease commonly treated with extended periods of bed rest and immobilization. The primary focus of the trial is to conduct a prospective short-term intervention to prevent an uncoupling of bone turnover in inpatients hospitalized for AN, and to determine the long-term effects of a biomechanical intervention on skeletal health in ambulatory adolescents with AN.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 11 Years 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 11-25 years
- •Diagnosis of anorexia nervosa based on DSM-IV criteria
- •Female gender
- •English-speaking
排除标准
- •• Concomitant chronic diseases which affect bone health, such as cystic fibrosis, inflammatory bowel disease, celiac disease, renal disease, or diabetes mellitus
- •Use of medications known to affect bone metabolism in the last 3 months, such as:
- •Glucocorticoid therapy (including inhaled steroids)
- •Anticonvulsants
- •Combined estrogen/progestin contraceptive agents (oral contraceptive pills)
- •Depot medroxyprogesterone (Depo-Provera) use in the last 12 months
- •Current pregnancy
研究组 & 干预措施
Placebo platform
Placebo Comparator
Randomized to stand on placebo platform for 10 minutes/day
干预措施: Low-magnitude mechanical stimulation platform (Device)
Low-magnitude mechanical stimulation
Active Comparator
Randomized to stand on LMMS platform 10 minutes/daily
干预措施: Low-magnitude mechanical stimulation platform (Device)
结局指标
主要结局
Change From Baseline in C-telopeptides
时间窗: Baseline to 5 days
次要结局
- Change From Baseline in Bone Specific Alkaline Phosphatase(baseline to 5 days)
研究者
Amy DiVasta
Principal Investigator
Boston Children's Hospital
研究点 (1)
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