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Bone Loss in Patients With Anorexia Nervosa

Physiopathology of Bone Loss in Young Patient With Anorexia Nervosa

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01907464
Enrollment
320
Registered
2013-07-25
Start date
2011-09-01
Completion date
2017-04-25
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Anorexia Nervosa

Keywords

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

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.

Interventions

OTHERclinical parameters description

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

OTHERpara clinical parameters description

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

OTHERhormonal parameters dosing

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

OTHERbone modeling markers dosing

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

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
14 Years to 38 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Dual-X-ray absorptiometry (DEXA)at Day 0 (time of the inclusion visit)The primary outcome is to model the bone mass acquisition in young women with anorexia nervosa.

Secondary

MeasureTime frameDescription
Biological parameters identificationAt day 0 (time of the inclusion visit)One of the secondary outcome is to identify biological factors associated with bone demineralisation.
clinical parameters identificationAt Day 0 (at time of the the inclusion visit)One of the secondary outcome is to identify the clinical factors associated with bone demineralisation.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORPatrick PL LEFEBVRE, MD

University Hospital, Montpellier

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026