orditropin Treatment in Subjects with Noonan Syndrome. Effects on Linear Growth and Final Height - Data Collection and Follow-up Visit

• Conditions: oonan syndrome associated short stature; MedDRA version: 7.1Level: PTClassification code 10029748

• Registration Number: EUCTR2005-000042-37-SE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

The present inclusion criteria are
•Informed consent before any trial related activities
•Participation in the original Norditropin® study (S/GHD/004/NOO) or following the protocol for S/GHD/004/NOO without being randomised in the trial
The original inclusion criteria were
•Verbal informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
•Children with Noonan Syndrome. The diagnostic criteria will be

oShort stature
oHypertelorism
oLow set ears
oAnd one of the following criteria:
?Ptosis
?Cubiti valga
?Testicular dysplasia
?Hypogonadotroph hypogonadism
•Bone age determination showing no significant acceleration (more than one year above chronological age) according to Greulich and Pyle (14). Patients showing an accelerated bone age (> chronological age) at the first examination will be reevaluated within 6 weeks before treatment start in order to evaluate the development process
•Age at start of the treatment
Age: 3.00-11.99 years
•Prepubertal according to Tanner standards:
< stage 2 with testes < 4 ml (boys) and no breast development (girls)
•Height < -2 SD of the used Swedish National growth standards (15)taranger
•Height velocity below 1 SD during the 12 months pre-treatment period (15)
•Normal thyroid function
•Normal karyotype
•Available height data since birth
•Parent heights available
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The original exclusion criteria were
•Earlier or ongoing treatment with growth hormone, anabolic steroids or corticosteroids
•Subjects with congenital heart defect perceived to possibly have a major impact on growth
•History of or actual endocrine, metabolic or other serious chronic disease perceived to possibly have a major impact on growth
•Fasting blood glucose consistently above 6.7 mmol/l
•Growth hormone deficiency defined as
oGH levels below 10 µg/l during two consecutive GH stimulation tests

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified