Bone Microarchitecture Evaluation by HR-pQCT in Youngs Who Developed AN in Peri or Prepubertal Period.

NCT02526927 | Completed

• 2 other identifiers: 14080822015-A00100-49
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Keywords

Anorexia Nervosa; microarchitecture; prepubertal

Outcome Measures

Primary Outcomes (1)

• Cortical thickness

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

  Day 1

Secondary Outcomes (3)

• Number of patients with bone degradation

  Day 1

• number of patients with osteoporosis

  Day 1

• Clinical and biological phenotype of AN patients 20 years-old or less

  Day 1

Study Arms (2)

Patients 20 - 30 years-old

EXPERIMENTAL

HR-pQCT and DEXA for measure bone quality and quantity

Device: HR-pQCT; Device: DEXA

Patients 10 - 20 years-old

EXPERIMENTAL

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

Device: HR-pQCT; Device: DEXA; Other: Blood samples

Interventions

HR-pQCT DEVICE

The Xtrem CT scanco device is a HR-pQCT used for 3D bone measurements at the tibia and the radius levels in human

Also known as: Xtrem CT scanco

Patients 10 - 20 years-old; Patients 20 - 30 years-old

DEXA DEVICE

The Lunar DEXA (Dual Energy X-ray Absorptiometry) is a third generation multi-captor DEXA device that allows short duration measurements (\< 15 min). It measures Bone Mineral Density at the spine (L1-L4) and the femoral neck

Patients 10 - 20 years-old; Patients 20 - 30 years-old

Blood samples OTHER

Patients 10 - 20 years-old

Eligibility Criteria

• Age: 10 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Anorexia Nervosa

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Thierry THOMAS, MD PhD

  CHU de SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: August 18, 2015
• Study Start: November 23, 2015
• Primary Completion: November 29, 2017
• Study Completion: November 29, 2017
• Last Updated: February 22, 2018

Record last verified: 2018-02

Locations

FR (1)