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

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HR-pQCT
DEXA
Blood samples
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anorexia Nervosa focused on measuring Anorexia Nervosa, microarchitecture, prepubertal

Eligibility Criteria

10 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de SAINT-ETIENNE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients 20 - 30 years-old

Patients 10 - 20 years-old

Arm Description

HR-pQCT and DEXA for measure bone quality and quantity

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of patients with bone degradation
Bone degradation is a composite outcome measured by cortical and architectural parameters measured with HR pQCTon 3D images of distal radius and distal tibia. The parameters are : Total volumetric bone mineral density (mg/ccm HA), Trabecular volumetric bone mineral density (mg/ccm HA), Cortical volumetric bone mineral density (mg/ccm HA), Number of bone trabeculae (1/mm), Trabecular thickness (mm) Cortical thickness (mm), Trabecular spacing (mm), Trabecular distribution (mm)
number of patients with osteoporosis
Osteoporosis is measured with DEXA. DEXA measure the Bone Mineral Density (g/cm2)
Clinical and biological phenotype of AN patients 20 years-old or less
Clinical and biological phenotype of AN patients 20 years-old or less is a composite factor : Pubertal stage at disease onset, Duration of AN, Height shortening compared to optimal genetically defined height, Serum levels of FGF23, Serum levels of IGF 1, Serum levels of sexual steroids (FSH, LH, oestradiol, testosterone, SeBG, AMH, inhibin B), Serum levels of bone formation and resorption markers (cross laps, osteocalcin, total alkaline phosphatases), Serum levels of leptin, Bone mineral density measured by DXA

Full Information

First Posted
August 17, 2015
Last Updated
February 20, 2018
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT02526927
Brief Title
Bone Microarchitecture Evaluation by HR-pQCT in Youngs Who Developed AN in Peri or Prepubertal Period.
Acronym
AMOS
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 23, 2015 (Actual)
Primary Completion Date
November 29, 2017 (Actual)
Study Completion Date
November 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Anorexia Nervosa, microarchitecture, prepubertal

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients 20 - 30 years-old
Arm Type
Experimental
Arm Description
HR-pQCT and DEXA for measure bone quality and quantity
Arm Title
Patients 10 - 20 years-old
Arm Type
Experimental
Arm Description
Blood samples, HR-pQCT and DEXA for measure bone quality and quantity
Intervention Type
Device
Intervention Name(s)
HR-pQCT
Other Intervention Name(s)
Xtrem CT scanco
Intervention Description
The Xtrem CT scanco device is a HR-pQCT used for 3D bone measurements at the tibia and the radius levels in human
Intervention Type
Device
Intervention Name(s)
DEXA
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Blood samples
Primary Outcome Measure Information:
Title
Cortical thickness
Description
Cortical thickness (in mm) is a composite outcome measured with HR pQCTon 3D images of distal radius and distal tibia.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Number of patients with bone degradation
Description
Bone degradation is a composite outcome measured by cortical and architectural parameters measured with HR pQCTon 3D images of distal radius and distal tibia. The parameters are : Total volumetric bone mineral density (mg/ccm HA), Trabecular volumetric bone mineral density (mg/ccm HA), Cortical volumetric bone mineral density (mg/ccm HA), Number of bone trabeculae (1/mm), Trabecular thickness (mm) Cortical thickness (mm), Trabecular spacing (mm), Trabecular distribution (mm)
Time Frame
Day 1
Title
number of patients with osteoporosis
Description
Osteoporosis is measured with DEXA. DEXA measure the Bone Mineral Density (g/cm2)
Time Frame
Day 1
Title
Clinical and biological phenotype of AN patients 20 years-old or less
Description
Clinical and biological phenotype of AN patients 20 years-old or less is a composite factor : Pubertal stage at disease onset, Duration of AN, Height shortening compared to optimal genetically defined height, Serum levels of FGF23, Serum levels of IGF 1, Serum levels of sexual steroids (FSH, LH, oestradiol, testosterone, SeBG, AMH, inhibin B), Serum levels of bone formation and resorption markers (cross laps, osteocalcin, total alkaline phosphatases), Serum levels of leptin, Bone mineral density measured by DXA
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry THOMAS, MD PhD
Organizational Affiliation
CHU de SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de SAINT-ETIENNE
City
Saint-etienne
ZIP/Postal Code
42000
Country
France

12. IPD Sharing Statement

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

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