Dosage according to IGF1 response in growth hormone defi

$0M01FY2001RRNIH

Yale University, New Haven CT

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Abstract

The primary objective of this study is to test whether a fixed weight-based regimen of Somatropin (recombinant human growth hormone (rhGH) (Humatrope), starting with 4.0 ug/kg/day for four months and increasing to 8 ug/kg/day for two months, followed by 12 ug/kg/day for another two months, is equivalent or superior to an individualized Humatrope dose regimen, starting with 200 ug/day and adjusted by 200 ug/day increments at two-monthly intervals based on IGF-1 response for a further six months. Efficacy will primarily be assessed from changes in body composition determined from the results of fat mass measurements obtained by dual-energy x-ray absorptiometry (DXA) scanning performed at baseline and at the 8 month endpoint.

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