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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00490191

Enrollment

387

Registered

2007-06-22

Start date

1999-01-31

Completion date

2001-07-31

Last updated

2007-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypopituitarism

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 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.

Interventions

DRUGSomatropin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Percent change in total fat mass	Eight months

Secondary

Measure	Time frame
Safety	Eight months

Countries

France, Germany, Italy, Puerto Rico, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026