Severe Decrease of Growth Velocity in Children With Anorexia Nervosa.Therapeutic Trial of Growth Hormone
Condition: Anorexia Nervosa; Interruption of Growth; Delayed Puberty; Osteopenia With Failure of Acquisition of Bone Mass
MeSH terms: Bone Diseases, Metabolic; Puberty, Delayed; Anorexia; Anorexia Nervosa
Study type: Interventional
Phase: Phase 2/Phase 3

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. 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.
    

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.
    

Intervention name(s): SOMATROPINE* : Norditropine® simplexx®; Placebo
Intervention type(s): Drug; Biological
Intervention description(s): 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.; 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 intervention name(s): SOMATROPINE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: anorexia nervosa; GH; Growth velocity