Bone Loss in Patients With Anorexia Nervosa

Study Overview
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Brief Summary
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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.

Official Title
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Physiopathology of Bone Loss in Young Patient With Anorexia Nervosa

Conditions
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Patients With Anorexia Nervosa

Intervention / Treatment
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* Other: clinical parameters description
* Other: para clinical parameters description
* Other: hormonal parameters dosing
* Other: bone modeling markers dosing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent Health Insurance regimen or benefit from an health insurance regimen Aged from 14 to 38 years old Women 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with anorexia nervosa<br>This arm is the experimental arm composed of patients | Other: clinical parameters description<br>* description of weight, height, Bone Mass Index, dietary questionnary, amenorrhea time, pathology time for the two arms<br>Other: para clinical parameters description<br>* description of DMO, mass, basal metabolism, IGF-1/IGFBP-3 for the two arms<br>Other: hormonal parameters dosing<br>* dosing of leptine, leptine receptor, adiponectine, ghreline for the two arms<br>Other: bone modeling markers dosing<br>* dosing of osteocalcine, bone alkalin phosphatase, C-telopeptide of type-I collagene, osteoprotegerine/ RANKL for the two arms<br>|
| Active Comparator: controls subjects<br>This arm is composed of healthy volunteers | Other: clinical parameters description<br>* description of weight, height, Bone Mass Index, dietary questionnary, amenorrhea time, pathology time for the two arms<br>Other: para clinical parameters description<br>* description of DMO, mass, basal metabolism, IGF-1/IGFBP-3 for the two arms<br>Other: hormonal parameters dosing<br>* dosing of leptine, leptine receptor, adiponectine, ghreline for the two arms<br>Other: bone modeling markers dosing<br>* dosing of osteocalcine, bone alkalin phosphatase, C-telopeptide of type-I collagene, osteoprotegerine/ RANKL for the two arms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dual-X-ray absorptiometry (DEXA) | The primary outcome is to model the bone mass acquisition in young women with anorexia nervosa. | at Day 0 (time of the inclusion visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological parameters identification | One of the secondary outcome is to identify biological factors associated with bone demineralisation. | At day 0 (time of the inclusion visit) | 
| clinical parameters identification | One of the secondary outcome is to identify the clinical factors associated with bone demineralisation. | At Day 0 (at time of the the inclusion visit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anorexia nervosa, Bone mineral density, Teenagers or young women, Bone remodelling markers