Clinical trial NCT02526927: Bone Microarchitecture Evaluation by HR-pQCT in Youngs Who Developed AN in Peri or Prepubertal Period.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Anorexia Nervosa
microarchitecture
prepubertal
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-08-18
Enrollment: 34
Sex: ALL
Minimum age (years): 10
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Cortical thickness
timeFrame: Day 1
Secondary outcomes:
measure: Number of patients with bone degradation
timeFrame: Day 1
measure: number of patients with osteoporosis
timeFrame: Day 1
measure: Clinical and biological phenotype of AN patients 20 years-old or less
timeFrame: Day 1
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Thierry THOMAS, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: