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

This study is not yet open for participant recruitment.
Verified June 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Novo Nordisk
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01626833
First received: June 21, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Anorexia Nervosa
Catch- Down or Even an Interruption of Growth,
Delayed Puberty
Osteopenia With Failure of Acquisition of Bone Mass
 Drug: SOMATROPINE* : Norditropine® simplexx®
Biological: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Severe Decrease of Growth Velocity in Children With Anorexia Nervosa. Therapeutic Trial of Growth Hormone

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • the growth-velocity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • growth-velocity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.

  • Body composition [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.

  • Psychological changes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Psychological changes that will be assessed between the 2 arms at the end of the two years of clinical trial.


Estimated Enrollment: 20
Study Start Date: September 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Somatropine Drug: SOMATROPINE* : Norditropine® simplexx®
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.
Other Name: SOMATROPINE
Placebo Comparator: Placebo Biological: Placebo
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.
Other Name: Placebo

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.

  Eligibility

Ages Eligible for Study:   8 Years to 203 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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).

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626833

Contacts
Contact: Leger Juliane, PhD 01 4 0 03 23 54 juliane.leger@rdb.aphp.fr

Locations
France
Robert Debré Hospital Not yet recruiting
Paris, France, 75019
Contact: Leger Juliane, PhD     01 40 03 23 54        
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Novo Nordisk
Investigators
Principal Investigator: Leger Juliane, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01626833     History of Changes
Other Study ID Numbers: P090903, 2010-018560-16
Study First Received: June 21, 2012
Last Updated: June 21, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
anorexia nervosa
GH
Growth velocity

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Bone Diseases, Metabolic
Puberty, Delayed
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders
 Bone Diseases
Musculoskeletal Diseases
Gonadal Disorders
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013