NCT02891356

Brief Summary

The mechanism of bone loss in anorexia nervosa is complex. Marrow adipose tissue seems to play a role in the regulation of bone metabolism. Adipocytes secrete cytokines and adipokines that either stimulate or inhibit adjacent osteoblasts. This study consist to explore the relationship in anorexia nervosa patients with change in bone mineral density and adipokines like leptin, adiponectin and Préf-1 Bone mineral densities will be measure in 180 anorexia nervosa patients at inclusion and every two years during 6 years.It is assessed blood and urinary calcium and phosphate levels, bone remodelling markers and adipokines (leptin, adiponectin and Préf-1)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 8, 2025

Status Verified

November 1, 2025

Enrollment Period

9.4 years

First QC Date

September 1, 2016

Last Update Submit

December 2, 2025

Conditions

Keywords

AdiponectinBone remodelling markers

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density by Dual Energy X-ray Absorptiometry (DEXA)

    measured the evolution of the bone mineral density in 180 anorexia nervosa patients and the relationship with this change and adipokine

    4 years

Secondary Outcomes (3)

  • Incidence of osteoporotic fractures

    at 2,4 and 6 years

  • Adiponectin plasma concentration by ELISA

    at 2,4 and 6 years

  • Interleukin-7 plasma concentration by ELISA

    at 2,4 and 6 years

Study Arms (1)

Anorexia patient

Dual Energy X-ray Absorptiometry (DEXA)

Device: DEXA

Interventions

DEXADEVICE

The Dual Energy X-ray Absorptiometry (DEXA) is a third generation multi-captor DEXA device that allow short duration measurements. It measures Bone Mineral Density (BMD) at the spine and the femoral neck

Anorexia patient

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Anorexia patient recruted in psychiatric unit ( hospitalisation and consultation visit)

You may qualify if:

  • anorexia patient defined by DSM IV diagnostic criteria

You may not qualify if:

  • patient with other psychiatric disease
  • patient with other a metabolic bone disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Roger Salengro, CHRU de Lille

Lille, France

Location

MeSH Terms

Conditions

Anorexia NervosaOsteoporosis

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Isabelle LEGROUX, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 7, 2016

Study Start

July 1, 2013

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

December 8, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations