Online Surveillance of Treatment of Children With Growth Hormone Deficiency With ZOMACTON

Non-interventional Study With ZOMACTON in Children With Growth Hormone Deficiency

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01365351

Enrollment

1034

Registered

2011-06-03

Start date

2007-12-01

Completion date

2016-06-30

Last updated

2017-06-02

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

Conditions

Growth Hormone Deficiency

Brief summary

The purpose of this study is to investigate long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner syndrome.

Interventions

OTHERGrowth hormone

Drug given by prescription

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* therapeutic need according to SPC * written informed consent

Exclusion criteria

* contraindications according to SPC

Design outcomes

Primary

Measure	Time frame	Description
Efficacy of ZOMACTON	Up to 5 years	measured by: body height, increase of body height per annum

Secondary

Measure	Time frame	Description
Efficacy measured by further parameters	Up to 5 years	measured by: weight, increase weight per annum sitting height, increase of sitting height per annum head circumference per annum bone age, increase of bone age per annum puberty development IGF-1, IGFBP-3 psychological cofactors
Safety of Zomacton and application device	Up to 5 years	measured by: local adverse reactions to the application device adverse events of Zomacton safety laboratory

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026