|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01907464 |
|
Date of registration:
|
17/07/2013 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Bone Loss in Patients With Anorexia Nervosa
|
|
Scientific title:
|
Physiopathology of Bone Loss in Young Patient With Anorexia Nervosa |
|
Date of first enrolment:
|
September 2011 |
|
Target sample size:
|
320 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01907464 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Laurent LM MAIMOUN, PhD |
|
Address:
|
|
|
Telephone:
|
+33 4 67 33 79 99 |
|
Email:
|
l-maimoun@chu-montpellier.fr |
|
Affiliation:
|
|
|
|
Name:
|
Patrick PL LEFEBVRE, MD |
|
Address:
|
|
|
Telephone:
|
+33 4 67 33 84 31 |
|
Email:
|
p-lefebvre@chu-montpellier.fr |
|
Affiliation:
|
|
|
|
Name:
|
Patrick PL LEFEBVRE, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University Hospital, Montpellier |
|
|
Key inclusion & exclusion criteria
|
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
Age minimum:
14 Years
Age maximum:
38 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Patients With Anorexia Nervosa
|
|
Intervention(s)
|
|
Other: bone modeling markers dosing
|
|
Other: para clinical parameters description
|
|
Other: hormonal parameters dosing
|
|
Other: clinical parameters description
|
|
Primary Outcome(s)
|
|
Dual-X-ray absorptiometry (DEXA)
[Time Frame: at Day 0 (time of the inclusion visit)]
|
|
Secondary Outcome(s)
|
|
Biological parameters identification
[Time Frame: At day 0 (time of the inclusion visit)]
|
|
clinical parameters identification
[Time Frame: At Day 0 (at time of the the inclusion visit)]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|