Anorexia NervosaAMOSNCT02891356
Bone Mass Changes in Anorexia Nervosa Patient Followed During 4 Years
An observational study of Anorexia Nervosa and Osteoporosis, run by University Hospital, Lille at 1 site in France.
Trial summary
The mechanism of bone loss in anorexia nervosa is complex. Marrow adipose tissue seems to play a role in the regulation of bone metabolism. Adipocytes secrete cytokines and adipokines that either stimulate or inhibit adjacent osteoblasts. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Anorexia Nervosa, Osteoporosis
- What is being tested?
- DEXA
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Dec 2022
- Phase
- Observational
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Anorexia patient recruted in psychiatric unit ( hospitalisation and consultation visit)
Who may be able to join
- anorexia patient defined by DSM IV diagnostic criteria
Who cannot join
- patient with other psychiatric disease
- patient with other a metabolic bone disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bone Mass Changes in Anorexia Nervosa Patient Followed During 4 Years and Relationship Between Bone Loss and Adipokines.
The mechanism of bone loss in anorexia nervosa is complex. Marrow adipose tissue seems to play a role in the regulation of bone metabolism. Adipocytes secrete cytokines and adipokines that either stimulate or inhibit adjacent osteoblasts. This study consist to explore the relationship in anorexia nervosa patients with change in bone mineral density and adipokines like leptin, adiponectin and Préf-1 Bone mineral densities will be measure in 180 anorexia nervosa patients at inclusion and every two years during 6 years.It is assessed blood and urinary calcium and phosphate levels, bone remodelling markers and adipokines (leptin, adiponectin and Préf-1)
- Conditions
- Anorexia Nervosa, Osteoporosis
- Being tested
- DEXA
- Keywords
- Adiponectin, Bone remodelling markers
- Medical subject headings
- Anorexia Nervosa, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXADevice
The Dual Energy X-ray Absorptiometry (DEXA) is a third generation multi-captor DEXA device that allow short duration measurements. It measures Bone Mineral Density (BMD) at the spine and the femoral neck
| Study group | Role | What they receive |
|---|---|---|
| Anorexia patient | Dual Energy X-ray Absorptiometry (DEXA) Receives: Device: DEXA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density by Dual Energy X-ray Absorptiometry (DEXA)
measured the evolution of the bone mineral density in 180 anorexia nervosa patients and the relationship with this change and adipokine
Measured: 4 years
Secondary outcomes (3)
Incidence of osteoporotic fractures
Measured: at 2,4 and 6 years
Adiponectin plasma concentration by ELISA
measurement of circulating biological factors predicative of changes in BMD
Measured: at 2,4 and 6 years
Interleukin-7 plasma concentration by ELISA
measurement of circulating biological factors predicative of changes in BMD
Measured: at 2,4 and 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startJul 2013
- Primary completionDec 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle LEGROUX, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891356
- Sponsor's protocol ID
- 2011_38
- Other IDs
- 2012-A01009-34
- Acronym
- AMOS
- Status last verified
- Nov 2025
- First submitted
- 1 Sep 2016
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Mass Changes in Anorexia Nervosa Patient Followed During 4 Years and Relationship Between Bone Loss and Adipokines.
- ClinicalTrials.gov ID
- NCT02891356
- Acronym / sponsor ID
- AMOS / 2011_38
- Conditions
- Anorexia Nervosa, Osteoporosis
- Keywords
- Adiponectin, Bone remodelling markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 7 Sep 2016 (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.
The mechanism of bone loss in anorexia nervosa is complex. Marrow adipose tissue seems to play a role in the regulation of bone metabolism. Adipocytes secrete cytokines and adipokines that either stimulate or inhibit adjacent osteoblasts. This study consist to explore the relationship in anorexia nervosa patients with change in bone mineral density and adipokines like leptin, adiponectin and Préf-1 Bone mineral densities will be measure in 180 anorexia nervosa patients at inclusion and every two years during 6 years.It is assessed blood and urinary calcium and phosphate levels, bone remodelling markers and adipokines (leptin, adiponectin and Préf-1)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anorexia patient | – | Device: DEXADual Energy X-ray Absorptiometry (DEXA) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Anorexia patient recruted in psychiatric unit ( hospitalisation and consultation visit)
Key inclusion criteria (1 listed)
- anorexia patient defined by DSM IV diagnostic criteria
Key exclusion criteria (2 listed)
- patient with other psychiatric disease
- patient with other a metabolic bone disease
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 |
|---|---|---|
| DEXAThe Dual Energy X-ray Absorptiometry (DEXA) is a third generation multi-captor DEXA device that allow short duration measurements. It measures Bone Mineral Density (BMD) at the spine and the femoral neck | Device | Anorexia patient |
Primary outcome
Bone mineral density by Dual Energy X-ray Absorptiometry (DEXA)
Time frame: 4 years
measured the evolution of the bone mineral density in 180 anorexia nervosa patients and the relationship with this change and adipokine
3 secondary outcomes
Incidence of osteoporotic fractures
Time frame: at 2,4 and 6 years
Adiponectin plasma concentration by ELISA
Time frame: at 2,4 and 6 years
Interleukin-7 plasma concentration by ELISA
Time frame: at 2,4 and 6 years
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 8 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Isabelle LEGROUX, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa and Osteoporosis, run by University Hospital, Lille 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 1 inclusion and 2 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 8 Dec 2025. 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?
Bone mineral density by Dual Energy X-ray Absorptiometry (DEXA) (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2025.