Clinical Trial: Comparison of Two Growth Hormone Dosing Methods in Adults With Growth Hormone Deficiency

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparison of an Incremental Weight-Based Dose Regimen With an Individualized Dosage Adjusted According to the IGF-I Response in Adults With Growth Hormone Deficiency

Brief Summary: This study tested whether a dose regimen of growth hormone based on body weight is equivalent or better than starting with a low dose and gradually increasing the dose according to individual patient needs. Efficacy of the two regimens were assessed from changes in body fat measured by dual-energy x-ray absorptiometry (DXA) scanning, performed at the beginning of the study and at the completion of the study eight months later.

Detailed Summary:

Dose regimen of growth hormone based on weight: Starting dose was 4.0 micrograms/kg/day for four months, then increased to 8 micrograms/kg/day for two months, and then increased to 12 micrograms/kg/day for a further two months (eight months in total).

Dose regimen of growth hormone based on individual patient needs: Starting dose was 200 micrograms/day, then increased by 200 micrograms/day every two months for an additional six months (eight months in total) as needed for optimal treatment results.

Sponsor: Eli Lilly and Company

Current Primary Outcome: Percent change in total fat mass [ Time Frame: Eight months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Safety [ Time Frame: Eight months ]

Original Secondary Outcome: Same as current

Information By: Eli Lilly and Company

Dates:
Date Received: June 20, 2007
Date Started: January 1999
Date Completion:
Last Updated: June 20, 2007
Last Verified: June 2007