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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.


- candidate number1598
- NTR NumberNTR380
- ISRCTNISRCTN52337368
- Date ISRCTN created19-dec-2005
- date ISRCTN requested28-okt-2005
- Date Registered NTR12-sep-2005
- Secondary IDsN/A 
- Public TitleA 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.
- Scientific TitleA 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.
- ACRONYMDose-response study
- hypothesisThe change in biochemical parameters of bone and colleagen metabolism during a shortterm GH dose-response study predicts the long-term effect of GH on growth. Idiopathic short stature is partially explainable by an abnormal tissue responsiveness to GH and IGF-I. GH theray in a dosage of 6 IU//mw.day administered before puberty increases height velocity, height in adolescence and final height. GH administration affects puberty onset and its duration. GH administration affects quality of life.
- Healt Condition(s) or Problem(s) studiedIdiopathic Short Stature (ISS)
- Inclusion criteria40 children. Height SDS<-2, prepubertal, age 4-8 (F) or 4-10 (M), GH response to provocation tests >20 mU/l, normal sitting height.height ratio, normal screening blood tests and urinanalysis.
- Exclusion criteriaAny systemic disease during childhood that limits the growth potential or may interfere with the evaluation of the effectiveness of therapy.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jan-1994
- planned closingdate1-jan-2009
- Target number of participants40
- InterventionsAfter 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 (1.5 IU/m2.d, 3.0 IU/m2.d) with 3 months washout periods in between. Thereafter 6 IU/m2.d was given until the beginning of puberty.
- Primary outcomeHeight at stop of therapy (at onset of puberty) and final height.
- Secondary outcome1. 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.
- Timepoints
- Trial web siteN/A
- statusinclusion stopped: follow-up
- 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)
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Organization for Scientific Research (NWO)
- PublicationsKamp, G.A., Rekers-Mombarg L.T.M., Wit, J.M. Does GH treatment affect pubertal timing in children with idiopathic short stature? Highlights 1997;5:12-15. 205.
Kamp, G.A., Wit, J.M. High-dose growth hormone therapy in idiopathic short stature. Horm Res 1998;49 (suppl 2):67-72. 238.
Rekers-Mombarg, L.T.M., Kamp, G.A., Massa, G.G., Wit, J.M. Influence of growth hormone treatment on pubertal timing and pubertal growth in children with idiopathic short stature. J Pediatr Endocrinol Metab 1999;12 (5):611-622 287.
Theunissen N.C.M., Kamp, G.A., Koopman, H.M., Zwinderman, K.A.H., Vogels, M.A., Wit, J.M. Quality of life and self esteem in children treated for idiopathic short stature. J.Pediatrics, 2002;140:507-15 288.
Kamp, G.A. Waelkens, J.J.J., De Muinck Keizer-Schrama, S.M.P.F., Delemarre-van de Waal, H.A., Verhoeven-Wind, L., Wit, J.M. High dose growth hormone treatment induces acceleration of skeletal maturation and an earlier onset of puberty in children with idiopathic short stature. Arch Dis Child, 2002;87:215-220289.
Kamp, G.A., Ouwens, D.M., Hoogerbrugge, C.M., Zwinderman, A.H., Maassen, J.A., Wit, J.M. Skin fibroblasts of children with idiopathic short stature show an increased mitogenic response to IGF-I and secrete more IGFBP-3 compared to normal children. Clin Endocrinol 2002;56:439-447 294.
Kamp, G.A. , Zwinderman, A.H., Doorn, J. van, Hackeng, W., Frölich, M., Schönau, E., Wit, J.M. Biochemical markers of growth hormone (GH) sensitivity in children with idiopathic short stature: individual capacity of IGF-I generation after high dose GH treatment determines the growth response to GH. Clin Endocrinol 2002; 57:315-325
- Brief summaryThe predictive power of the diagnostic phase (dose-response relationship, in vitro responsiveness of skin fibroblasts) is limited. GH accelerates puberty onset and duration. No clear effect on quality of life was found.
- Main changes (audit trail)
- RECORD12-sep-2005 - 6-mrt-2006


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