Bone Loss in Patients With Anorexia Nervosa

Physiopathology of Bone Loss in Young Patient With Anorexia Nervosa

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.

Study Overview

• Status: Unknown
• Conditions: Patients With Anorexia Nervosa
• Intervention / Treatment: Other: clinical parameters description; Other: para clinical parameters description; Other: hormonal parameters dosing; Other: bone modeling markers dosing

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick PL LEFEBVRE, MD; Phone Number: +33 4 67 33 84 31; Email: p-lefebvre@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • CHU de Montpellier - Département d'Endocrinologie Diabète
    • Contact: Laurent LM MAIMOUN, PhD; Phone Number: +33 4 67 33 79 99; Email: l-maimoun@chu-montpellier.fr
    • Principal Investigator: Patrick PL LEFEBVRE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 38 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Patrick PL LEFEBVRE, MD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: July 17, 2013
• First Submitted That Met QC Criteria: July 22, 2013
• First Posted (Estimate): July 25, 2013

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Bone mineral density; Anorexia nervosa; Bone remodelling markers; Teenagers or young women
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: UF 8751