Clinical trial: Treatment of Children With Insufficient Secretion of Growth Hormone (NCT00271518)

Eligibility criteria:
Inclusion Criteria:

          -  Pre-pubertal children (boys age: > 3 and <12 years or girls: age >3 and <11 years)
             with isolated GH insufficiency, GH insufficiency as part of multiple pituitary hormone
             deficiencies, or organic GH insufficiency. If GH insufficiency occurred after
             treatment for any brain tumour, the patient has to be at least one year in clinical
             remission which has to be confirmed by computer tomography (CT) or magnetic resonance
             imaging (MRI) scan (with contrast) within 3 months prior to study entry

          -  Children with negative signs for intracranial tumour or tumour growth as confirmed
             with a CT or MRI scan (with contrast) within 12 months prior to inclusion or at
             inclusion visit

          -  Confirmed diagnosis of GH insufficiency as determined by two different GH provocation
             tests, defined as a peak plasma GH level of ≤7 ng/ml

          -  No prior exposure to rhGH therapy (GH-treatment naive)

          -  Height (HT), except in children suffering from organic GH insufficiency, of at least
             2.0 standard deviations (SD) (HT SDS £-2.0) below the mean height for chronological
             age (CA) and sex according to the 2000 standards from the Centers for Disease Control
             and Prevention (CDC).

          -  Height velocity (HV) of at least 1 SD (HV SDS £-1) below the mean HV for CA and sex
             according to the standards of Prader. The minimum time between two standard height
             measurements should be at least 6 month before inclusion.

          -  Baseline IGF-I level of at least 0.5 SD (IGF-1 SDS£-0.5) below the mean IGF-1 level
             standardised for age and sex according to the central laboratory reference values.

          -  Written informed consent of parent or legal guardian of subject.

        Exclusion Criteria:

          -  Any clinically significant abnormality likely to affect growth or the ability to
             evaluate growth, such as, but not limited to, chronic diseases like renal
             insufficiency, spinal cord irradiation, and malnutrition (BMI must be above -2SD and
             below +2SD of mean BMI for the chronological age and sex according to the CDC
             standards, and albumin must be above lower limit of normal (LLN) of the central
             laboratory for a patient to be included).

          -  Patients with overt diabetes mellitus (Fasting blood sugar >126 mg/dl) and impaired
             fasting sugar (Fasting blood sugar >100 mg/dl after repeated blood analysis)

          -  Chromosomal abnormalities and medical "syndromes" (Turner's syndrome, Laron syndrome,
             Noonan syndrome or absence of growth hormone receptors), with the exception of
             septo-optic dysplasia

          -  Congenital abnormalities (causing skeletal abnormalities), Russell-Silver Syndrome,
             skeletal dysplasias

          -  Closed epiphyses

          -  Other growth promoting medication such as anabolic steroids, with the exception of
             pituitary hormone replacement therapy, thyroxine, hydrocortisone and desmopressin
             (DDAVP) replacement therapies

          -  Children requiring glucocorticoid therapy (e.g. asthma) that are on the dose of more
             than 400 µg/d of inhaled budesonide or equivalents inhaled for longer than 1 month
             during a calendar year

          -  Bone age (BA) higher than chronological age

          -  Poorly controlled or uncontrolled pituitary insufficiencies of other axes (e.g.,
             thyroid-stimulating hormone, adrenocorticotropic hormone/cortisol, vasopressin
             deficiency): Children who are on stable replacement therapy for less than 6 months for
             thyroid replacement therapy, and less than 3 months for other hormonal deficiencies
             prior to enrolment

          -  Major medical conditions and/or presence of contraindication to rhGH treatment

          -  Known or suspected HIV-positive patient or patient with advanced diseases such as AIDS
             or tuberculosis

          -  Drug, substance, or alcohol abuse

          -  Known hypersensitivity to the components of study medication

          -  Evidence of tumour growth or malignant disease

          -  Presence of anti-hGH antibodies at screening

          -  The patient and/or the parent/legal guardian are likely to be non-compliant in respect
             to study conduct.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 11 Years

Patient description (medical language): A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively.  On physical examination, the patient's height is in the 5th percentile of her age.  Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus.  Chromosomal analysis reveals a 45, XO karyotype.

Patient description (patient's own words): I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype.

Does the patient match the trial criteria? Contradiction