NordiNet International Outcome Study (NordiNet IOS) - NordiNet IOS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001674-32-FI

Enrollment

17000

Registered

2008-08-25

Start date

2009-04-29

Completion date

Unknown

Last updated

2017-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Gestation Age, Turner Syndrome, Growth Hormone Deficiency MedDRA version: 16.1 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders

Interventions

Trade Name: Norditropin Pharmaceutical Form: Injection INN or Proposed INN: somatotropine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The study population will consist of children and adults who are on treatment with Norditropin® in accordance with normal clinical practice. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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

Exclusion criteria: As per Norditropin SPC

Design outcomes

Primary

Measure	Time frame
Main Objective: To collect the post-marketing data on effectiviness and safety of real-life treatment with Norditropin.;Secondary Objective: To gather the data of patients using Norditropin to same data base (NordiNet) to help the clinicians every-day work.;Primary end point(s): Effectiviness endpoints: effect of Norditropin on height gain, glucose metabolism, the cardiovascular system, body weight/composition, blood chemistry, bone status, primary tumour occurrence or reoccurrence, the endocrine system and pubertal development. Safety endpoints: adverse reactions and severe adverse events, deteriorative changes in clinical and laboratory parameters.	—

Measure

Time frame

Main Objective: To collect the post-marketing data on effectiviness and safety of real-life treatment with Norditropin.;Secondary Objective: To gather the data of patients using Norditropin to same data base (NordiNet) to help the clinicians every-day work.;Primary end point(s): Effectiviness endpoints: effect of Norditropin on height gain, glucose metabolism, the cardiovascular system, body weight/composition, blood chemistry, bone status, primary tumour occurrence or reoccurrence, the endocrine system and pubertal development. Safety endpoints: adverse reactions and severe adverse events, deteriorative changes in clinical and laboratory parameters.

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Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026