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A study on the efficacy of the combination of growth hormone and gonadotropin releasing hormone analogues (GnRHa) on adult height in children with idiopathic short stature.

A study on the efficacy of the combination of growth hormone and gonadotropin releasing hormone analogues (GnRHa) on adult height in children with idiopathic short stature.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23928
Enrollment
40
Registered
2005-09-12
Start date
1993-10-01
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

Idiopathic short stature or persistent short stature after being born small for gestational age.

Interventions

Daily injections of Growth Hormone (GH) and monthly injections with GnRHa (Decapeptyl) for 3 years. Regular controls at the clinic, blood investigations for effect and safety parameters, yearly X-ra

Sponsors

Pfizer Inc, New York, through Dutch affiliate (Capelle a/d Ijssel) and Ferring (Denmark), through Dutch affiliate (Hoofddorp)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 40 adolescents in early puberty, with a height <-2 SDS or with a height SDS between -1 and -2, but a predicted adult height SDS <-2.

Exclusion criteria

Exclusion criteria: Disorders or medication influencing growth.

Design outcomes

Primary

MeasureTime frame
Final height SDS minus initial height SDS.

Secondary

MeasureTime frame
1. Final height SDS; 2. Final height SDS minus initial height SDS; 3. Final height SDS minus target height; 4. Body mass index; 5. Bone mineral density; 6. 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)