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Effects of two different GH doses in children with growth hormone deficiency


- candidate number4204
- NTR NumberNTR1484
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-okt-2008
- Secondary IDsNL/GHV/101/GHD 
- Public TitleEffects of two different GH doses in children with growth hormone deficiency
- Scientific TitleDose response study in growth hormone therapy of growth hormone deficient children follow-up (> 2years) study.
- ACRONYMN/A
- hypothesisA higher GH dose leads to a higher adult height
- Healt Condition(s) or Problem(s) studiedGrowth hormone deficiency, Dose response study
- Inclusion criteria1. Documented GHD of organic or idiopathic origin, including isolated GHD as well as multiple pituitary hormone deficiencies;
2. BA < 12 for boys and < 10 yr for girls, determined according to the procedure of Tanner and Whitehouse, 20 bones (TW2-20)
3. Normal serum T4 levels
4. No signs of puberty
- Exclusion criteria1. Growth retardation due to diabetes mellitus, inborn error of metabolism, primary bone disease, disorders of cardiopulmonary, gastrointestinal, genitourinary, or nervous tracts, or serious suspicion of psychosocial dwarfism;
2. Any kind of drug that might interfere with GH therapy, with the exception of replacement doses of T4 and/or hydrocortisone in multiple hormone deficiencies;
3. Insufficient growth response to previous GH therapy.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 18-aug-1987
- planned closingdate9-mrt-2004
- Target number of participants35
- InterventionsTwo doses of biosynthetic GH:
0.7 mg/m2/d (~0.025 mg/kg/d) or 1.4 mg/m2/d (~0.050 mg/kg/d).
- Primary outcome- Adult height; attained AH minus target height (TH)
- Secondary outcome- Adverse events
- Timing of puberty
- Bone maturation
- Timepointsvisit: every 3 months at the out patient clinic until adult height has been reached
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES T.C.J. Sas
- CONTACT for SCIENTIFIC QUERIES T.C.J. Sas
- Sponsor/Initiator Novo Nordisk
- Funding
(Source(s) of Monetary or Material Support)
Novo Nordisk Farma B.V.
- Publications- de Muinck Keizer-Schrama SM, Rikken B, Wynne HJ, Hokken-Koelega AC, Wit JM, Bot A, Drop SL 1992 Dose-response study of biosynthetic human growth hormone (GH) in GH-deficient children: effects on auxological and biochemical parameters. Dutch Growth Hormone Working Group. J Clin Endocrinol Metab74:898-905

- De Muinck Keizer-Schrama S, Rikken B, Hokken-Koelega A, Wit JM, Drop S 1994 Comparative effect of two doses of growth hormone for growth hormone deficiency. The Dutch Growth Hormone Working Group. Arch Dis Child 71:12-18
- Brief summaryA higher increase in height velocity with a higher GH dose.
- Main changes (audit trail)
- RECORD9-okt-2008 - 19-okt-2008


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