Bone Loss in Patients With Anorexia Nervosa

Patients With Anorexia Nervosa Clinical Trial

Official title:

Physiopathology of Bone Loss in Young Patient With Anorexia Nervosa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01907464
• Other study ID #: UF 8751
• Status: Recruiting
• Phase: N/A
• First received: July 17, 2013
• Last updated: December 2, 2014
• Start date: September 2011
• Est. completion date: September 2015

Study information

• Verified date: December 2014
• Source: University Hospital, Montpellier
• Contact: Patrick PL LEFEBVRE, MD
• Phone: +33 4 67 33 84 31
• Email: p-lefebvre[@]chu-montpellier.fr
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 38 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Patients With Anorexia Nervosa

Intervention

Other:
• clinical parameters description
description of weight, height, Bone Mass Index, dietary questionnary, amenorrhea time, pathology time for the two arms
• para clinical parameters description
description of DMO, mass, basal metabolism, IGF-1/IGFBP-3 for the two arms
• hormonal parameters dosing
dosing of leptine, leptine receptor, adiponectine, ghreline for the two arms
• bone modeling markers dosing
dosing of osteocalcine, bone alkalin phosphatase, C-telopeptide of type-I collagene, osteoprotegerine/ RANKL for the two arms

Locations

Country	Name	City	State
France	CHU de Montpellier - Département d'Endocrinologie Diabète	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No