Bone Loss in Patients With Anorexia Nervosa

NCT ID: NCT01907464

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-09-30

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.

Detailed Description

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Conditions

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Patients With Anorexia Nervosa

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Patients with anorexia nervosa

This arm is the experimental arm composed of patients

Group Type EXPERIMENTAL

clinical parameters description

Intervention Type OTHER

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

para clinical parameters description

Intervention Type OTHER

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

hormonal parameters dosing

Intervention Type OTHER

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

bone modeling markers dosing

Intervention Type OTHER

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

controls subjects

This arm is composed of healthy volunteers

Group Type ACTIVE_COMPARATOR

clinical parameters description

Intervention Type OTHER

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

para clinical parameters description

Intervention Type OTHER

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

hormonal parameters dosing

Intervention Type OTHER

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

bone modeling markers dosing

Intervention Type OTHER

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

Interventions

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clinical parameters description

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

Intervention Type OTHER

para clinical parameters description

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

Intervention Type OTHER

hormonal parameters dosing

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

Intervention Type OTHER

bone modeling markers dosing

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

Intervention Type OTHER

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


Patient suffering from anorexia nervosa defined by criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)


* 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
Minimum Eligible Age

14 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick PL LEFEBVRE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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CHU de Montpellier - Département d'Endocrinologie Diabète

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrick PL LEFEBVRE, MD

Role: CONTACT

+33 4 67 33 84 31

Facility Contacts

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Laurent LM MAIMOUN, PhD

Role: primary

+33 4 67 33 79 99

Other Identifiers

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UF 8751

Identifier Type: -

Identifier Source: org_study_id