Bone Loss in Patients With Anorexia Nervosa

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01907464
First received: July 17, 2013
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Patients With Anorexia Nervosa
Other: clinical parameters description
Other: para clinical parameters description
Other: hormonal parameters dosing
Other: bone modeling markers dosing

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Physiopathology of Bone Loss in Young Patient With Anorexia Nervosa

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Dual-X-ray absorptiometry (DEXA) [ Time Frame: at Day 0 (time of the inclusion visit) ] [ Designated as safety issue: No ]
    The primary outcome is to model the bone mass acquisition in young women with anorexia nervosa.


Secondary Outcome Measures:
  • Biological parameters identification [ Time Frame: At day 0 (time of the inclusion visit) ] [ Designated as safety issue: No ]
    One of the secondary outcome is to identify biological factors associated with bone demineralisation.

  • clinical parameters identification [ Time Frame: At Day 0 (at time of the the inclusion visit) ] [ Designated as safety issue: No ]
    One of the secondary outcome is to identify the clinical factors associated with bone demineralisation.


Estimated Enrollment: 320
Study Start Date: September 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients with anorexia nervosa
This arm is the experimental arm composed of patients
Other: clinical parameters description
description of weight, height, Bone Mass Index, dietary questionnary, amenorrhea time, pathology time for the two arms
Other: para clinical parameters description
description of DMO, mass, basal metabolism, IGF-1/IGFBP-3 for the two arms
Other: hormonal parameters dosing
dosing of leptine, leptine receptor, adiponectine, ghreline for the two arms
Other: bone modeling markers dosing
dosing of osteocalcine, bone alkalin phosphatase, C-telopeptide of type-I collagene, osteoprotegerine/ RANKL for the two arms
Active Comparator: controls subjects
This arm is composed of healthy volunteers
Other: clinical parameters description
description of weight, height, Bone Mass Index, dietary questionnary, amenorrhea time, pathology time for the two arms
Other: para clinical parameters description
description of DMO, mass, basal metabolism, IGF-1/IGFBP-3 for the two arms
Other: hormonal parameters dosing
dosing of leptine, leptine receptor, adiponectine, ghreline for the two arms
Other: bone modeling markers dosing
dosing of osteocalcine, bone alkalin phosphatase, C-telopeptide of type-I collagene, osteoprotegerine/ RANKL for the two arms

  Eligibility

Ages Eligible for Study:   14 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01907464

Contacts
Contact: Patrick PL LEFEBVRE, MD +33 4 67 33 84 31 p-lefebvre@chu-montpellier.fr

Locations
France
CHU de Montpellier - Département d'Endocrinologie Diabète Recruiting
Montpellier, France, 34295
Contact: Laurent LM MAIMOUN, PhD    +33 4 67 33 79 99    l-maimoun@chu-montpellier.fr   
Principal Investigator: Patrick PL LEFEBVRE, MD         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Patrick PL LEFEBVRE, MD University Hospital, Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01907464     History of Changes
Other Study ID Numbers: UF 8751
Study First Received: July 17, 2013
Last Updated: July 22, 2013
Health Authority: France: Committee for the Protection of Personnes
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Montpellier:
Anorexia nervosa
Bone mineral density
Teenagers or young women
Bone remodelling markers

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014