Comparison of Two Growth Hormone Dosing Methods in Adults With Growth Hormone Deficiency
- Conditions
- Hypopituitarism
- Registration Number
- NCT00490191
- Lead Sponsor
- Eli Lilly and Company
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 387
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percent change in total fat mass Eight months
- Secondary Outcome Measures
Name Time Method Safety Eight months
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇬🇧Manchester, Lancashire, United Kingdom