Long Term Follow up Study of Predictive Markers in GHD and TS Children

Completed

• Conditions: Growth Hormon Deficiency; Turner Syndrome in Pre-pubertal Children

• Registration Number: NCT00699855
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief Summary

Primary objective is to assess the relationship between changes from serum biomarkers observed after 1 month of Saizen® therapy and change in height, weight after up to 5 years of treatment with Growth Hormone in children with Growth Hormone Deficiency (GHD) and Turner Syndrome (TS).

Detailed Description

This study is an observational study that will collect data from patients enrolled in a previous study (PREDICT, NCT 00256126). Data such as auxological parameters (height, weight, Tanner stage, bone age will be collected as well as GH treatment use (including dose and adherence to the treatment).

Because for some countries the start of this long term follow up study will take place more than one year after subjects have completed the initial study (PREDICT) retrospective data may be collected (if subjects agree) as well as prospective data.

When available laboratory parameters such as IGF-1, IGFPB-3, fasting glucose, fasting insulin, TSH and T4 will also be collected.

This data will be collected yearly during the normal follow up visits during 5 years.

Study Timeline

• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-17
• Study First Posted: 2008-06-18
• Study Start: 2008-09
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-17
• Last Update Posted: 2014-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

• Have completed the PREDICT study (NCT 00256126)
• Followed up at least 1 year when still under treatment after completion of PREDICT Trial
• Parent's or guardian's written consent given before any data collection

Exclusion Criteria

• Use of an investigational drug or participation in another interventional clinical trial since discontinuation of PREDICT trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Data such as auxological parameters (height, weight, Tanner stage, bone age) will be collected as well as GH treatment use (including dose and adherence to the treatment).	Yearly

Secondary Outcome Measures

Name	Time	Method
When available laboratory parameters such as IGF-1, IGFPB-3, fasting glucose, fasting insulin, TSH and T4 will also be collected.	Yearly