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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

March 31, 2021

Study Completion Date

March 31, 2021

Conditions
Anorexia NervosaInterruption of GrowthDelayed PubertyOsteopenia With Failure of Acquisition of Bone Mass
Interventions
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.

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.

Trial Locations (1)

75019

Robert Debré Hospital, Paris

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novo Nordisk A/S

INDUSTRY

lead

Assistance Publique - Hôpitaux de Paris

OTHER