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

NCT01626833 | Completed Phase 2

• 2 other identifiers: P0909032010-018560-16
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anorexia Nervosa; Interruption of Growth; Delayed Puberty; Osteopenia With Failure of Acquisition of Bone Mass

Keywords

anorexia nervosa; GH; Growth velocity

Outcome Measures

Primary Outcomes (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

  1 year

Secondary Outcomes (3)

• growth-velocity

  2 years

• Body composition

  2 years

• Psychological changes

  2 years

Study Arms (2)

SOMATROPINE* : Norditropine® simplexx®

ACTIVE COMPARATOR

SOMATROPINE\* : Norditropine® simplexx®

Drug: SOMATROPINE* : Norditropine® simplexx®

Placebo

PLACEBO COMPARATOR

Placebo

Biological: Placebo

Interventions

SOMATROPINE* : Norditropine® simplexx® DRUG

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.

Also known as: SOMATROPINE

SOMATROPINE* : Norditropine® simplexx®

Placebo BIOLOGICAL

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.

Placebo

Eligibility Criteria

• Age: 8 Years - 203 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Robert Debré Hospital

Paris, 75019, France

Location

Related Publications (1)

• 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.

  PMID: 33772303 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa; Puberty, Delayed

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Leger Juliane, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2012
• First Posted: June 25, 2012
• Study Start: March 1, 2013
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: June 8, 2021

Record last verified: 2021-05

Locations

FR (1)