Bone Mass Changes in Anorexia Nervosa Patient Followed During 4 Years (AMOS)

August 24, 2020 updated by: University Hospital, Lille

Bone Mass Changes in Anorexia Nervosa Patient Followed During 4 Years and Relationship Between Bone Loss and Adipokines.

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lille, France
        • Recruiting
        • Hôpital Roger Salengro, CHRU de Lille
        • Principal Investigator:
          • Isabelle LEGROUX, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • anorexia patient defined by DSM IV diagnostic criteria

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anorexia patient
Dual Energy X-ray Absorptiometry (DEXA)
Device: DEXA
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone mineral density by Dual Energy X-ray Absorptiometry (DEXA)
Time Frame: 4 years
measured the evolution of the bone mineral density in 180 anorexia nervosa patients and the relationship with this change and adipokine
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of osteoporotic fractures
Time Frame: at 2,4 and 6 years
at 2,4 and 6 years
Adiponectin plasma concentration by ELISA
Time Frame: at 2,4 and 6 years
measurement of circulating biological factors predicative of changes in BMD
at 2,4 and 6 years
Interleukin-7 plasma concentration by ELISA
Time Frame: at 2,4 and 6 years
measurement of circulating biological factors predicative of changes in BMD
at 2,4 and 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Isabelle LEGROUX, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

September 1, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 24, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011_38
  • 2012-A01009-34 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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