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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.


- candidate number1583
- NTR NumberNTR373
- ISRCTNISRCTN82161629
- Date ISRCTN created19-dec-2005
- date ISRCTN requested28-okt-2005
- Date Registered NTR12-sep-2005
- Secondary IDsN/A 
- Public TitleA 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.
- Scientific TitleA 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.
- ACRONYMGH+GnRHa study
- hypothesisA combined treatment of GH and GnRHa for 3 years in short adolescents with relatively early puberty leads to final height gain.
- Healt Condition(s) or Problem(s) studiedSmall for gestational age (SGA), Children with persistent short stature
- Inclusion criteria40 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 criteriaDisorders or medication influencing growth.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-1993
- planned closingdate1-jul-2006
- Target number of participants40
- InterventionsDaily 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-rays of the hand, and yearly psychological assessment.
At final height, growth, psychological assessment, bone mineral density.
- Primary outcomeFinal height SDS minus initial height SDS.
- Secondary outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. Dr. J.M. Wit
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.M. Wit
- Sponsor/Initiator Pfizer B.V. (Pfizer Inc, New York), FERRING B.V. (FERRING - Denmark)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU), Netherlands Organization for Scientific Research (NWO)
- PublicationsJ Clin Endocrinol Metab. 2007 Apr;92(4):1402-8. Epub 2007 Feb 6.
- Brief summaryGH plus GnRHa for 3 years leads to an increase of predicted adult height. At final height an average gain of 4 cm is found (manuscript in preparation).
- Main changes (audit trail)
- RECORD12-sep-2005 - 26-nov-2008


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