Patients With Anorexia NervosaNCT01907464
Bone Loss in Patients With Anorexia Nervosa
A study testing clinical parameters description, para clinical parameters description and hormonal parameters dosing in people with Patients With Anorexia Nervosa, run by University Hospital, Montpellier at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Patients With Anorexia Nervosa
- What is being tested?
- clinical parameters description, para clinical parameters description and hormonal parameters dosing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to 25 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 38 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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:
Show all 11Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
CHU de Montpellier - Département d'Endocrinologie Diabète
Montpellier, 34295
About this study
Official title: Physiopathology of Bone Loss in Young Patient With Anorexia Nervosa
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.
- Conditions
- Patients With Anorexia Nervosa
- Being tested
- clinical parameters description, para clinical parameters description, hormonal parameters dosing, bone modeling markers dosing
- Keywords
- Anorexia nervosa, Bone mineral density, Teenagers or young women, Bone remodelling markers
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical parameters descriptionOther
description of weight, height, Bone Mass Index, dietary questionnary, amenorrhea time, pathology time for the two arms
para clinical parameters descriptionOther
description of DMO, mass, basal metabolism, IGF-1/IGFBP-3 for the two arms
hormonal parameters dosingOther
dosing of leptine, leptine receptor, adiponectine, ghreline for the two arms
bone modeling markers dosingOther
dosing of osteocalcine, bone alkalin phosphatase, C-telopeptide of type-I collagene, osteoprotegerine/ RANKL for the two arms
| Study group | Role | What they receive |
|---|---|---|
| Patients with anorexia nervosa | Experimental | This arm is the experimental arm composed of patients Receives: Other: clinical parameters description; Other: para clinical parameters description; Other: hormonal parameters dosing; Other: bone modeling markers dosing |
| controls subjects | Active comparator | This arm is composed of healthy volunteers Receives: Other: clinical parameters description; Other: para clinical parameters description; Other: hormonal parameters dosing; Other: bone modeling markers dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual-X-ray absorptiometry (DEXA)
The primary outcome is to model the bone mass acquisition in young women with anorexia nervosa.
Measured: at Day 0 (time of the inclusion visit)
Secondary outcomes (2)
Biological parameters identification
One of the secondary outcome is to identify biological factors associated with bone demineralisation.
Measured: At day 0 (time of the inclusion visit)
clinical parameters identification
One of the secondary outcome is to identify the clinical factors associated with bone demineralisation.
Measured: At Day 0 (at time of the the inclusion visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startSep 2011
- Primary completionApr 2017
- Study completion25 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patients With Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick PL LEFEBVRE, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907464
- Sponsor's protocol ID
- 8751
- Status last verified
- May 2026
- First submitted
- 17 Jul 2013
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Maimoun L, Guillaume S, Lefebvre P, Philibert P, Bertet H, Picot MC, Gaspari L, Paris F, Seneque M, Dupuys AM, Courtet P, Thomas E, Mariano-Goulart D, Bringer J, Renard E, Sultan C. Evidence of a link between resting energy expenditure and bone remodelling, glucose homeostasis and adipokine variations in adolescent girls with anorexia nervosa. Osteoporos Int. 2016 Jan;27(1):135-46. doi: 10.1007/s00198-015-3223-x. Epub 2015 Aug 6.
PubMed 26245848Maimoun L, Guillaume S, Lefebvre P, Philibert P, Bertet H, Picot MC, Courtet P, Mariano-Goulart D, Renard E, Sultan C. Is Serum Serotonin Involved in the Bone Loss of Young Females with Anorexia Nervosa? Horm Metab Res. 2016 Mar;48(3):174-177. doi: 10.1055/s-0035-1559632. Epub 2015 Sep 29.
PubMed 26418163Maimoun L, Guillaume S, Lefebvre P, Philibert P, Bertet H, Picot MC, Gaspari L, Paris F, Courtet P, Thomas E, Mariano-Goulart D, Bringer J, Renard E, Sultan C. Role of sclerostin and dickkopf-1 in the dramatic alteration in bone mass acquisition in adolescents and young women with recent anorexia nervosa. J Clin Endocrinol Metab. 2014 Apr;99(4):E582-90. doi: 10.1210/jc.2013-2565. Epub 2014 Jan 28.
PubMed 24471564
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiopathology of Bone Loss in Young Patient With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT01907464
- Acronym / sponsor ID
- 8751
- Conditions
- Patients With Anorexia Nervosa
- Keywords
- Anorexia nervosa, Bone mineral density, Teenagers or young women, Bone remodelling markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Apr 2017 (actual)
- Study completion
- 25 Apr 2017 (actual)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with anorexia nervosa | Experimental | Other: clinical parameters description, Other: para clinical parameters description, Other: hormonal parameters dosing, Other: bone modeling markers dosingThis arm is the experimental arm composed of patients |
| controls subjects | Active comparator | Other: clinical parameters description, Other: para clinical parameters description, Other: hormonal parameters dosing, Other: bone modeling markers dosingThis arm is composed of healthy volunteers |
Who may qualify
- Ages
- 14 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Informed Consent
- Health Insurance regimen or benefit from an health insurance regimen
- Aged from 14 to 38 years old
- Women
- No pregnant
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical parameters descriptiondescription of weight, height, Bone Mass Index, dietary questionnary, amenorrhea time, pathology time for the two arms | Other | Patients with anorexia nervosa, controls subjects |
| para clinical parameters descriptiondescription of DMO, mass, basal metabolism, IGF-1/IGFBP-3 for the two arms | Other | Patients with anorexia nervosa, controls subjects |
| hormonal parameters dosingdosing of leptine, leptine receptor, adiponectine, ghreline for the two arms | Other | Patients with anorexia nervosa, controls subjects |
| bone modeling markers dosingdosing of osteocalcine, bone alkalin phosphatase, C-telopeptide of type-I collagene, osteoprotegerine/ RANKL for the two arms | Other | Patients with anorexia nervosa, controls subjects |
Primary outcome
Dual-X-ray absorptiometry (DEXA)
Time frame: at Day 0 (time of the inclusion visit)
The primary outcome is to model the bone mass acquisition in young women with anorexia nervosa.
2 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Results publication: PubMed 26245848Maimoun L, Guillaume S, Lefebvre P, Philibert P, Bertet H, Picot MC, Gaspari L, Paris F, Seneque M, Dupuys AM, Courtet P, Thomas E, Mariano-Goulart D, Bringer J, Renard E, Sultan C. Evidence of a link between resting energy expenditure and bone remodelling, glucose homeostasis and adipokine variations in adolescent girls with anorexia nervosa. Osteoporos Int. 2016 Jan;27(1):135-46. doi: 10.1007/s00198-015-3223-x. Epub 2015 Aug 6.
- Results publication: PubMed 26418163Maimoun L, Guillaume S, Lefebvre P, Philibert P, Bertet H, Picot MC, Courtet P, Mariano-Goulart D, Renard E, Sultan C. Is Serum Serotonin Involved in the Bone Loss of Young Females with Anorexia Nervosa? Horm Metab Res. 2016 Mar;48(3):174-177. doi: 10.1055/s-0035-1559632. Epub 2015 Sep 29.
- Results publication: PubMed 24471564Maimoun L, Guillaume S, Lefebvre P, Philibert P, Bertet H, Picot MC, Gaspari L, Paris F, Courtet P, Thomas E, Mariano-Goulart D, Bringer J, Renard E, Sultan C. Role of sclerostin and dickkopf-1 in the dramatic alteration in bone mass acquisition in adolescents and young women with recent anorexia nervosa. J Clin Endocrinol Metab. 2014 Apr;99(4):E582-90. doi: 10.1210/jc.2013-2565. Epub 2014 Jan 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick PL LEFEBVRE, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clinical parameters description, para clinical parameters description and hormonal parameters dosing in people with Patients With Anorexia Nervosa, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual-X-ray absorptiometry (DEXA) (time frame: at Day 0 (time of the inclusion visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01907464, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.