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

Lilly

Status and phase

Completed

Phase 4

Conditions

Hypopituitarism

Treatments

Drug: Somatropin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00490191

2073

B9R-EW-T002

Details and patient eligibility

About

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.

Full description

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.

Enrollment

387 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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