Comparison of Two Growth Hormone Dosing Methods in Adults With Growth Hormone Deficiency

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

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.

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.

Inclusion Criteria:

• Have growth hormone deficiency that started in childhood or adulthood
• Have not received any growth hormone treatment in the last 12 months
• Have had a growth hormone stimulation test within the last two years showing abnormally low response
• Have received adequate and stable hormonal replacement for other hormone deficiencies during the last three months

Exclusion Criteria:

• Presence of clinically significant diseases, such as cancer, lung, heart, liver, kidney, neuromuscular, genetic, or severe psychiatric diseases
• Recent growth of pituitary tumor or other intracranial tumor
• History of acromegaly
• Taking medication to suppress appetite or reduce weight, or antidepressant drugs
• Poorly-controlled high blood pressure or diabetes