Physiopathology of Bone Loss in Young Patient With Anorexia Nervosa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Dual-X-ray absorptiometry (DEXA)
研究概览
简要总结
Nutritional deprivation of adolescent girls with anorexia nervosa (AN) reduces the bone mass acquisition. A better understanding of this process would improve the medical treatment of bone alteration and its long-term consequences.
160 patients (age < 38 yr) with AN and 160 age-matched controls (CON) will be enrolled in this study. The areal bone mineral density (aBMD) will be determined using dual-X-ray absorptiometry. Calciotropic hormones, bone turnover markers will be concomitantly evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 38 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Informed Consent
- •Health Insurance regimen or benefit from an health insurance regimen
- •Aged from 14 to 38 years old
- •No pregnant
- •Specific inclusion criteria for patient:
- •Patient suffering from anorexia nervosa defined by criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
- •Specific inclusion criteria for controls:
- •Normal menstrual cycles,
- •No lifetime history of eating disorders,
- •BMI between 18 and 25 kg/m²
排除标准
- •use of treatments may be modify bone mass (bisphosphonates,…)
- •Disease or treatment may be induce osteoporosis
- •In exclusion period in relation with another study
- •Law protected subject
研究组 & 干预措施
Patients with anorexia nervosa
This arm is the experimental arm composed of patients
干预措施: clinical parameters description (Other)
Patients with anorexia nervosa
This arm is the experimental arm composed of patients
干预措施: para clinical parameters description (Other)
Patients with anorexia nervosa
This arm is the experimental arm composed of patients
干预措施: hormonal parameters dosing (Other)
Patients with anorexia nervosa
This arm is the experimental arm composed of patients
干预措施: bone modeling markers dosing (Other)
controls subjects
This arm is composed of healthy volunteers
干预措施: clinical parameters description (Other)
controls subjects
This arm is composed of healthy volunteers
干预措施: para clinical parameters description (Other)
controls subjects
This arm is composed of healthy volunteers
干预措施: hormonal parameters dosing (Other)
controls subjects
This arm is composed of healthy volunteers
干预措施: bone modeling markers dosing (Other)
结局指标
主要结局
Dual-X-ray absorptiometry (DEXA)
时间窗: at Day 0 (time of the inclusion visit)
The primary outcome is to model the bone mass acquisition in young women with anorexia nervosa.
次要结局
- Biological parameters identification(At day 0 (time of the inclusion visit))
- clinical parameters identification(At Day 0 (at time of the the inclusion visit))