NCT02526927: AMOS

Bone Microarchitecture Evaluation by HR-pQCT in Youngs Who Developed AN in Peri or Prepubertal Period.

Completed NA Last updated 22 February 2018

What this trial tests

NA trial testing HR-pQCT in Anorexia Nervosa in 34 participants. Completed in 29 November 2017.

Timeline

23 November 2015

Primary endpoint
29 November 2017

29 November 2017

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Saint Etienne
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	other
Enrollment	34
Start date	23 November 2015
Primary completion	29 November 2017
Estimated completion	29 November 2017
Sites	1 location across France

Drugs / interventions tested

• HR-pQCT
• DEXA
• Blood samples — full drug profile →

Conditions studied

• Anorexia Nervosa — all drugs for Anorexia Nervosa →

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Who can join

Adults 10 to 30, any sex, with Anorexia Nervosa. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.