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Anorexia NervosaPhase 2/3OREXNCT01626833

Severe Decrease of Growth Velocity in Children With Anorexia Nervosa.Therapeutic Trial of Growth Hormone

A Phase 2/3 study testing SOMATROPINE* : Norditropine® simplexx® in people with Anorexia Nervosa and Interruption of Growth, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Anorexia nervosa may be responsible for a catch- down or even an interruption of growth, delayed puberty and osteopenia with failure of acquisition of bone mass. The recovery of normal nutrition usually leads to a resumption of growth and pubertal development. Read more about this study

Who is it for?
Ages 8 years to 203 months
What is being tested?
SOMATROPINE* : Norditropine® simplexx®
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
1 siteFrance
Study dates
Mar 2013to Mar 2021
Phase
Phase 2/3
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 8 years to 203 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Medical screening.
  • Female and male subjects aged 8-16 years and 11 months, with clinical anorexia nervosa and / or reference to the diagnostic criteria of DSM-IV (1) before or at early puberty (Tanner stage 1 or 2) and with a prolonged Catch-Down for at least 18 months (HV ≤ 2 cm / year), with bone age ≤ 12 years in girls and ≤14 years in boys.
  • Anorexia nervosa diagnosed at least 1 year before the study
  • Growth velocity documented for at least 18 months before inclusion
  • As with any child with a severe Catch-Down an assessment of GH secretion must be performed before inclusion (in the context of care) in the trial, which is not conditioned by the GH peak value : GH value of <20 miu / L will lead to the production of a brain MRI (in the context of care) that have to be normal (normal hypothalamic-pituitary axis and absence of tumor pathology) to allow Inclusion of the patient.
  • Normal glucose tolerance
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  • Stable metabolic state with of weight gain of at least 10% of body weight from the time the body mass index was the lowest in relation to the occurrence of the disease and normal blood electrolytes (no hypokalemia) .
  • Subjects whose holders have signed parental consent
  • Subjects whose holders of parental authority are affiliated to a social security scheme
  • CMU (CMU universal medical coverage).

Who cannot join

  • Subjects in the mid-puberty (Tanner stage 3 or 4) or with menarche.
  • Subjects with a chromosomal abnormality or other chronic disease associated chronic requiring long-term treatment.
  • Impaired glucose tolerance or diabetes.
  • Inability of the patient or the medical team to ensure the progress and monitoring under the protocol.
  • Participation in another trial.
  • Bradycardia ≤ 50 bpm.
  • Children whose holders of parental authority are not beneficiaries of social security
  • Contra-indication to SOMATROPINE

Trial locations and contacts

1 site in 1 country.

France1 site

  • Robert Debré Hospital

    Paris, 75019

Other trials in France

About this study

Official title: Severe Decrease of Growth Velocity in Children With Anorexia Nervosa. Therapeutic Trial of Growth Hormone

Anorexia nervosa may be responsible for a catch- down or even an interruption of growth, delayed puberty and osteopenia with failure of acquisition of bone mass. The recovery of normal nutrition usually leads to a resumption of growth and pubertal development. However, despite a therapeutic nutritional and psychotherapeutic satisfactory approach, some patients have a significant short stature with reduced adult final height and a deficit of bone mass. The main objective is to evaluate the effect of growth hormone (hGH) treatment on the growth velocity in prepubertal children or children in early puberty with anorexia nervosa and significant reduction of height velocity. This is a single-center, controlled, randomized and double-blind clinical trial evaluating the efficacy of hGH treatment for 1 year against a placebo, on the growth velocity of prepubertal or children in early puberty with Anorexia nervosa and major catch-down.This period is followed by the evaluation of the hGH treatment in children receiving placebo and continued hGH treatment in the treatment arm for 1 year, in total 2 years of study for each child. This second period corresponds to an ethical consideration giving secondarily access to treatment for patients in the placebo group.

Read the detailed description

Patients will be evaluated at baseline and at 3, 6, 9, 12, 15, 18, 21 and 24 months after the start of the trial. This evaluation will include a clinical evaluation and a biological (IGF-I, IGFBP-3, leptin, ghrelin, adiponectin, mineral metabolism, thyroid function, 24 hours urinary cortisol, as well as conventional electrolyte tolerance parameters), psychological and nutritional study body composition by absorptiometry at 0, 12 and 24 months. Evaluations will be conducted at the Center for Clinical Investigation at Hospital Robert Debre. The primary endpoint will be the linear growth rate 1 year after the start of the trial expressed in cm/1 year in the group with hGH compared to the placebo group. The secondary endpoints will be the height velocity expressed in SDS (standard deviation score), the data of body composition and psychological changes that will be assessed between the 2 arms at the end of the two years of the clinical trial. The data of body composition obtained by dual photon absorptiometry and biological data of mineral metabolism and growth factors are expressed in Z score compared to normal references that we have established in France, in healthy subjects according to age, gender and pubertal stage.

Being tested
SOMATROPINE* : Norditropine® simplexx®, Placebo
Keywords
anorexia nervosa, GH, Growth velocity
Medical subject headings
Anorexia Nervosa, Puberty, Delayed

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SOMATROPINE* : Norditropine® simplexx®Drug

    Also called SOMATROPINE

    SOMATROPINE* : Norditropine® simplexx® - 15 mg/1,5 ml, injectable solution:Treatment with hGH is administered at a dose of 0.05 mg / kg / day (0.35 mg / kg / week) subcutaneously daily, preferably in the evening. The dose of hGH treatment will be adjusted according to weight gain, and reduced by 10% if the serum values of IGF-I SDS above 2.5 on 2 consecutive determinations at 3-month intervals are discovered by the biologist.

  • PlaceboBiological

    Treatment with placebo is administered at a dose of 0.05 mg / kg / day (0.35 mg / kg / week) subcutaneously daily, preferably in the evening. The dose of placebo will be adjusted according to weight gain, and reduced by 10% if the serum values of IGF-I SDS above 2.5 on 2 consecutive determinations at 3-month intervals are discovered by the biologist.

Study groups in NCT01626833
Study groupRoleWhat they receive
SOMATROPINE* : Norditropine® simplexx®Active comparatorSOMATROPINE* : Norditropine® simplexx®
Receives: Drug: SOMATROPINE* : Norditropine® simplexx®
PlaceboPlacebo comparatorPlacebo
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the growth-velocity

    the growth velocity will be evaluated 1 year after the start of the trial (cm/1an) compared between the group with the placebo and hGH

    Measured: 1 year

Secondary outcomes (3)

  1. growth-velocity

    The secondary endpoints will be the growth-velocity expressed in SDS that will be assessed between the 2 arms at the end of the two years of clinical trial.

    Measured: 2 years

  2. Body composition

    The data of body composition that will be assessed between the 2 arms at the end of the two years of clinical trial. The data of body composition obtained by dual photon absorptiometry and biological data of mineral metabolism and growth factors are expressed in Z score compared to normal references that we have established in France, in healthy subjects according to age, gender and pubertal stage.

    Measured: 2 years

  3. Psychological changes

    Psychological changes that will be assessed between the 2 arms at the end of the two years of clinical trial.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2012 (estimated)
  2. Study startMar 2013
  3. Primary completionMar 2021
  4. Study completionMar 2021

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01626833
Sponsor's protocol ID
P090903
Other IDs
2010-018560-16
Acronym
OREX
Status last verified
May 2021
First submitted
21 Jun 2012
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No

Publications

  • Leger J, Fjellestad-Paulsen A, Bargiacchi A, Pages J, Chevenne D, Alison M, Alberti C, Guilmin-Crepon S. One Year of GH Treatment for Growth Failure in Children With Anorexia Nervosa: A Randomized Placebo-Controlled Trial. J Clin Endocrinol Metab. 2021 Jun 16;106(7):e2535-e2546. doi: 10.1210/clinem/dgab203.

    PubMed 33772303

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing SOMATROPINE* : Norditropine® simplexx® in people with Anorexia Nervosa and Interruption of Growth, run by Assistance Publique - Hôpitaux de Paris 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 10 inclusion and 8 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 27 Oct 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

the growth-velocity (time frame: 1 year). 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 NCT01626833, which also lists 1 linked publication.

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 27 Oct 2026.

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