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A study on the Tissue Responsiveness to short term exogenous GH in children with idiopathic short stature in relation to their reponse to long-term treatment.

A study on the Tissue Responsiveness to short term exogenous GH in children with idiopathic short stature in relation to their reponse to long-term treatment.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24302
Enrollment
40
Registered
2005-09-12
Start date
1994-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Children with idiopathic short stature (ISS)

Interventions

After randomisation, the control group did not receive treatment, and were followed yearly for growth and puberty assessment. The treatment group underwent two 3 months periods of GH administration (

Sponsors

Pfizer (New York) (previously Pharmacia), through local representatives in the Netherlands.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 40 children. Height SDS20 mU/l, normal sitting height.height ratio, normal screening blood tests and urinanalysis.

Exclusion criteria

Exclusion criteria: Any systemic disease during childhood that limits the growth potential or may interfere with the evaluation of the effectiveness of therapy.

Design outcomes

Primary

MeasureTime frame
Height at stop of therapy (at onset of puberty) and final height.

Secondary

MeasureTime frame
1. Timing of onset of puberty; - duration of puberty; 2. Relation between long-term growth response (dependent variable) and short-term growth response on various dosages and in vitro responsiveness of cultured skin fibroblasts to GH and IGF-I; 3. Effect of GH therapy on quality of life.

Contacts

Public ContactJ.M. Wit

Leiden University Medical Center (LUMC), Department of Pediatrics, P.O. Box 9600

j.m.wit@lumc.nl+31 (0)71 5262824

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)