Viewing Study NCT02526927



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Last Modification Date: 2024-10-26 @ 11:48 AM
Study NCT ID: NCT02526927
Status: COMPLETED
Last Update Posted: 2018-02-22
First Post: 2015-08-17

Brief Title: Bone Microarchitecture Evaluation by HR-pQCT in Youngs Who Developed AN in Peri or Prepubertal Period
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Organization: Centre Hospitalier Universitaire de Saint Etienne

Study Overview

Official Title: Monocentric Study Evaluating Bone Microarchitecture by High Resolution Quantitative Computerized Tomography HR-pQCT in Young Adults and Adolescents Who Developed Anorexia Nervosa AN in Peri or Prepubertal Period
Status: COMPLETED
Status Verified Date: 2018-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: AMOS
Brief Summary: The occurrence of anorexia nervosa AN during childhood or adolescence rapidly induces starvation stop of growth and impaired mineralization of bone tissue together with an interruption of pubertal development These consequences are initially reversible following food intake return but can lead to a more irreversible status with low height osteoporosis and high fracture risk The onset of the disease more and more early in life with the first stages of puberty suggest that these consequences will be even more severe as bone resistance will be damaged by more profound effects on bone growth as well It is therefore critical to evaluate these bone metabolism alterations in order to better manage these patients

At every age and in every clinical circumstance either physiologic or pathologic high resolution peripheral quantitative computerized tomography HRpQCT provides an evaluation of bone microarchitecture that is more informative than the global quantitative assessment given by conventional Dual Energy X-ray Absorptiometry DEXA with a better estimate of clinical fracture risk

Here we propose to measure cortical parameters such as cortical thickness which plays a key role in bone biomechanical strength in young adults aged between 20 and 30 years-old who had developed AN as early as the during the first stages of puberty but no longer present compared to age-and sex-matched healthy volunteers Other micro-architectural parameters will also be studied In an exploratory phase we will evaluate these bone microarchitectural parameters together with bone biological turnover markers and markers of sexual maturation in adolescents or young adults 20 years-old or less undernourished and currently managed for AN
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2015-A00100-49 OTHER ANSM None