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.
- Conditions
- Children with idiopathic short stature (ISS)
- Registration Number
- NL-OMON24302
- Lead Sponsor
- Pfizer (New York) (previously Pharmacia), through local representatives in the Netherlands.
- Brief Summary
Kamp, 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.<br> Kamp, G.A., Wit, J.M. High-dose growth hormone therapy in idiopathic short stature. Horm Res 1998;49 (suppl 2):67-72. 238. <br>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. <br>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. <br>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. <bR>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. <br>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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
40 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.
Any systemic disease during childhood that limits the growth potential or may interfere with the evaluation of the effectiveness of therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Height at stop of therapy (at onset of puberty) and final height.
- Secondary Outcome Measures
Name Time Method 1. Timing of onset of puberty; <br />- duration of puberty; <br /><br>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; <br /><br>3. Effect of GH therapy on quality of life.