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临床试验/NCT02526927
NCT02526927已完成不适用

Monocentric Study Evaluating Bone Microarchitecture by High Resolution Quantitative Computerized Tomography (HR-pQCT) in Young Adults and Adolescents Who Developed Anorexia Nervosa (AN) in Peri or Prepubertal Period.

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2015年11月23日最近更新:
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
34
试验地点
1
主要终点
Cortical thickness

研究概览

简要总结

The occurrence of anorexia nervosa (AN) during childhood or adolescence rapidly induces starvation, stop of growth and impaired mineralization of bone tissue together with an interruption of pubertal development. These consequences are initially reversible following food intake return but can lead to a more irreversible status with low height, osteoporosis and high fracture risk. The onset of the disease more and more early in life, with the first stages of puberty suggest that these consequences will be even more severe as bone resistance will be damaged by more profound effects on bone growth as well. It is therefore critical to evaluate these bone metabolism alterations in order to better manage these patients.

At every age and in every clinical circumstance either physiologic or pathologic, high resolution peripheral quantitative computerized tomography (HRpQCT) provides an evaluation of bone microarchitecture that is more informative than the global quantitative assessment given by conventional Dual Energy X-ray Absorptiometry) DEXA, with a better estimate of clinical fracture risk.

Here, we propose to measure cortical parameters, such as cortical thickness which plays a key role in bone biomechanical strength in young adults aged between 20 and 30 years-old, who had developed AN as early as the during the first stages of puberty but no longer present, compared to age-and sex-matched healthy volunteers. Other micro-architectural parameters will also be studied. In an exploratory phase, we will evaluate these bone microarchitectural parameters together with bone biological turnover markers and markers of sexual maturation in adolescents or young adults 20 years-old or less, undernourished and currently managed for AN.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
10 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients over 20 years old:
  • •Age > 20 and < 30 years old
  • •Patients managed for AN in the pediatric or endocrinology of the university hospital of St-Etienne
  • •Patients who developed AN as early as the during the first stages of puberty defined by Tanner stage 1 to 4, with a diagnosis of AN based on DSM-IV current criteria:
  • •Weight loss : deny of maintaining body weight over minimal normal threshold (85 % age and height matched)
  • •Intense fear of gaining weight or becoming obese despite weight insufficiency;
  • •Impaired perception of weight or dysmorphophobia;
  • •Excessive role of weight or body shape in self-esteem or deny of current leanness;
  • •Secondary amenorrhea during 3 or more menstrual cycles in young girls or primary amenorrhea
  • •Duration of AN of at least 6 months
  • •BMI >85% of theoretical BMI (efficient renutrition)
  • •Patients less than 20 years old :
  • •Age > 10 and < 20 years old
  • •Patients managed for AN in the pediatric or endocrinology of the university hospital of St-Etienne
  • •Patients who developed AN as early as the during the first stages of puberty defined by Tanner stage 1 to 4, with a diagnosis of AN based on DSM-IV current criteria:
  • •Weight loss : deny of maintaining body weight over minimal normal threshold (85 % age and height matched)
  • •Intense fear of gaining weight or becoming obese despite weight insufficiency;
  • •Impaired perception of weight or dysmorphophobia;
  • •Excessive role of weight or body shape in self-esteem or deny of current leanness;
  • •Secondary amenorrhea during 3 or more menstrual cycles in young girls or primary amenorrhea
  • •Duration of AN of at least 6 months

排除标准

  • •Renal insufficiency
  • •Dysthyroidism
  • •Inflammatory disease
  • •Pregnancy
  • •Lack of consent
  • •Subject under legal protection

研究组 & 干预措施

Patients 20 - 30 years-old

Experimental

HR-pQCT and DEXA for measure bone quality and quantity

干预措施: HR-pQCT (Device)

Patients 20 - 30 years-old

Experimental

HR-pQCT and DEXA for measure bone quality and quantity

干预措施: DEXA (Device)

Patients 10 - 20 years-old

Experimental

Blood samples, HR-pQCT and DEXA for measure bone quality and quantity

干预措施: Blood samples (Other)

Patients 10 - 20 years-old

Experimental

Blood samples, HR-pQCT and DEXA for measure bone quality and quantity

干预措施: HR-pQCT (Device)

Patients 10 - 20 years-old

Experimental

Blood samples, HR-pQCT and DEXA for measure bone quality and quantity

干预措施: DEXA (Device)

结局指标

主要结局

Cortical thickness

时间窗: Day 1

Cortical thickness (in mm) is a composite outcome measured with HR pQCTon 3D images of distal radius and distal tibia.

次要结局

  • Clinical and biological phenotype of AN patients 20 years-old or less(Day 1)
  • Number of patients with bone degradation(Day 1)
  • number of patients with osteoporosis(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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