Clinical trial: A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency (NCT02311894)

Eligibility criteria:
Inclusion Criteria:

          -  Bone age less than equal to (</=) 9 years (females) or </= 11 years (males) as
             determined by X-ray of the left hand and wrist using Greulich and Pyle method and
             obtained within the 12 months prior to enrollment

          -  Prepubertal (Tanner I) males and females by physical examination

          -  Diagnosis of GHD (stimulated GH less than [<] 10 nanograms per milliliter [ng/mL]) by
             two standard pharmacologic tests obtained up to 12 months prior to informed
             consent/assent

          -  Normal thyroid function test within the 12 months prior to informed consent/assent

          -  Normal complete blood counts within 12 months prior to informed consent/assent

          -  Documentation of prior height and weight measurements, with height standard deviation
             score (SDS) </= 5th percentile for idiopathic isolated GHD participants

        Exclusion Criteria:

          -  Any previous rhGH treatment

          -  Short stature etiologies other than GHD

          -  Acute critical illness or uncontrolled chronic illness, which in the opinion of the
             investigator and medical monitor, would interfere with participation in this study,
             interpretation of the data, or pose a risk to participant safety

          -  Chronic illnesses such as inflammatory bowel disease, celiac disease, heart disease,
             and diabetes

          -  Bone diseases such as achondroplasia or hypochondroplasia, intracranial tumor,
             irradiation, and traumatic brain injury

          -  Participants receiving oral or inhaled chronic corticosteroid therapy (greater than
             [>] 3 months) for other medical conditions other than central adrenal insufficiency

          -  Participants who require higher (2 times or greater than maintenance) doses of
             corticosteroids for more than 5 days in the 6 months prior to enrollment in the study

          -  Participants with active malignancy or any other condition that the investigator
             believes would pose a significant hazard to the participant if rhGH were initiated

          -  Females with Turner syndrome regardless of their GH status

          -  Prader-Willi syndrome regardless of GH status

          -  Born small for gestational age regardless of GH status

          -  Presence of scoliosis requiring monitoring

          -  Previous participation in another clinical trial or investigation of GH, treatment for
             growth failure, or treatment with a biologic agent

          -  Participants with closed epiphyses

          -  Participants with a known hypersensitivity to somatropin, excipients, or diluent
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 14 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