Bone Loss in Patients With Anorexia Nervosa

Not Applicable

• Conditions: Patients With Anorexia Nervosa
• Interventions: Other: clinical parameters description; Other: para clinical parameters description; Other: hormonal parameters dosing; Other: bone modeling markers dosing

• Registration Number: NCT01907464
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2013-07-17
• Study First Submitted QC: 2013-07-22
• Study First Posted: 2013-07-25
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03
• Primary Completion: 2015-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
controls subjects	hormonal parameters dosing	This arm is composed of healthy volunteers
Patients with anorexia nervosa	clinical parameters description	This arm is the experimental arm composed of patients
Patients with anorexia nervosa	para clinical parameters description	This arm is the experimental arm composed of patients
Patients with anorexia nervosa	hormonal parameters dosing	This arm is the experimental arm composed of patients
Patients with anorexia nervosa	bone modeling markers dosing	This arm is the experimental arm composed of patients
controls subjects	clinical parameters description	This arm is composed of healthy volunteers
controls subjects	para clinical parameters description	This arm is composed of healthy volunteers
controls subjects	bone modeling markers dosing	This arm is composed of healthy volunteers

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Biological parameters identification	At day 0 (time of the inclusion visit)	One of the secondary outcome is to identify biological factors associated with bone demineralisation.
clinical parameters identification	At Day 0 (at time of the the inclusion visit)	One of the secondary outcome is to identify the clinical factors associated with bone demineralisation.

Trial Locations

Locations (1)

CHU de Montpellier - Département d'Endocrinologie Diabète; 🇫🇷 Montpellier, France