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Bone Loss in Patients With Anorexia Nervosa

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Unknown

Conditions

Patients With Anorexia Nervosa

Treatments

Other: hormonal parameters dosing
Other: bone modeling markers dosing
Other: para clinical parameters description
Other: clinical parameters description

Study type

Interventional

Funder types

Other

Identifiers

NCT01907464
UF 8751

Details and patient eligibility

About

Nutritional deprivation of adolescent girls with anorexia nervosa (AN) reduces the bone mass acquisition. A better understanding of this process would improve the medical treatment of bone alteration and its long-term consequences.

160 patients (age < 38 yr) with AN and 160 age-matched controls (CON) will be enrolled in this study. The areal bone mineral density (aBMD) will be determined using dual-X-ray absorptiometry. Calciotropic hormones, bone turnover markers will be concomitantly evaluated.

Enrollment

320 estimated patients

Sex

Female

Ages

14 to 38 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

320 participants in 2 patient groups

Patients with anorexia nervosa
Experimental group
Description:
This arm is the experimental arm composed of patients
Treatment:
Other: hormonal parameters dosing
Other: clinical parameters description
Other: bone modeling markers dosing
Other: para clinical parameters description
controls subjects
Active Comparator group
Description:
This arm is composed of healthy volunteers
Treatment:
Other: hormonal parameters dosing
Other: clinical parameters description
Other: bone modeling markers dosing
Other: para clinical parameters description

Trial contacts and locations

1

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Central trial contact

Patrick PL LEFEBVRE, MD

Data sourced from clinicaltrials.gov

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