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

Observational Long-term Follow-up of the Phase IV Open-label Trial of Predictive Markers in GHD and TS Pre-pubertal Children Treated With Saizen

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00699855

Acronym

PREDICT LT FUP

Enrollment

182

Registered

2008-06-18

Start date

2008-09-30

Completion date

2012-08-31

Last updated

2014-02-19

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

Conditions

Growth Hormon Deficiency, Turner Syndrome in Pre-pubertal Children

Keywords

Growth Hormon Deficiency and, Turner Syndrome in pre-pubertal children, Long term follow-up of predictive markers

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.

Interventions

None listed

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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

Outcome results