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Bone Loss in Patients With Anorexia Nervosa

Primary Purpose

Patients With Anorexia Nervosa

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

clinical parameters description

para clinical parameters description

hormonal parameters dosing

bone modeling markers dosing

About this trial

This is an interventional basic science trial for Patients With Anorexia Nervosa focused on measuring Anorexia nervosa, Bone mineral density, Teenagers or young women, Bone remodelling markers

Eligibility Criteria

14 Years - 38 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

CHU de Montpellier - Département d'Endocrinologie DiabèteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients with anorexia nervosa

controls subjects

Arm Description

This arm is the experimental arm composed of patients

This arm is composed of healthy volunteers

Outcomes

Primary Outcome Measures

Dual-X-ray absorptiometry (DEXA)

The primary outcome is to model the bone mass acquisition in young women with anorexia nervosa.

Secondary Outcome Measures

Biological parameters identification

One of the secondary outcome is to identify biological factors associated with bone demineralisation.

clinical parameters identification

One of the secondary outcome is to identify the clinical factors associated with bone demineralisation.

Full Information

NCT ID

NCT01907464

First Posted

July 17, 2013

Last Updated

December 2, 2014

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT01907464

Brief Title

Bone Loss in Patients With Anorexia Nervosa

Official Title

Physiopathology of Bone Loss in Young Patient With Anorexia Nervosa

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Unknown status

Study Start Date

September 2011 (undefined)

Primary Completion Date

September 2015 (Anticipated)

Study Completion Date

September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patients With Anorexia Nervosa

Keywords

Anorexia nervosa, Bone mineral density, Teenagers or young women, Bone remodelling markers

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with anorexia nervosa

Arm Type

Experimental

Arm Description

This arm is the experimental arm composed of patients

Arm Title

controls subjects

Arm Type

Active Comparator

Arm Description

This arm is composed of healthy volunteers

Intervention Type

Other

Intervention Name(s)

clinical parameters description

Intervention Description

description of weight, height, Bone Mass Index, dietary questionnary, amenorrhea time, pathology time for the two arms

Intervention Type

Other

Intervention Name(s)

para clinical parameters description

Intervention Description

description of DMO, mass, basal metabolism, IGF-1/IGFBP-3 for the two arms

Intervention Type

Other

Intervention Name(s)

hormonal parameters dosing

Intervention Description

dosing of leptine, leptine receptor, adiponectine, ghreline for the two arms

Intervention Type

Other

Intervention Name(s)

bone modeling markers dosing

Intervention Description

dosing of osteocalcine, bone alkalin phosphatase, C-telopeptide of type-I collagene, osteoprotegerine/ RANKL for the two arms

Primary Outcome Measure Information:

Title

Dual-X-ray absorptiometry (DEXA)

Description

The primary outcome is to model the bone mass acquisition in young women with anorexia nervosa.

Time Frame

at Day 0 (time of the inclusion visit)

Secondary Outcome Measure Information:

Title

Biological parameters identification

Description

One of the secondary outcome is to identify biological factors associated with bone demineralisation.

Time Frame

At day 0 (time of the inclusion visit)

Title

clinical parameters identification

Description

One of the secondary outcome is to identify the clinical factors associated with bone demineralisation.

Time Frame

At Day 0 (at time of the the inclusion visit)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

38 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Patrick PL LEFEBVRE, MD

Phone

+33 4 67 33 84 31

p-lefebvre@chu-montpellier.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrick PL LEFEBVRE, MD

Organizational Affiliation

University Hospital, Montpellier

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Montpellier - Département d'Endocrinologie Diabète

City

Montpellier

ZIP/Postal Code

34295

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laurent LM MAIMOUN, PhD

Phone

+33 4 67 33 79 99

l-maimoun@chu-montpellier.fr

First Name & Middle Initial & Last Name & Degree

Patrick PL LEFEBVRE, MD

12. IPD Sharing Statement

Learn more about this trial

Bone Loss in Patients With Anorexia Nervosa

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