Comparison of Two Growth Hormone Dosing Methods in Adults With Growth Hormone Deficiency - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00490191

Purpose

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.

Condition	Intervention	Phase
Hypopituitarism	Drug: Somatropin	Phase IV

Genetics Home Reference related topics: pseudoachondroplasia

Drug Information available for: Insulin-like growth factor I Mecasermin rinfabate Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Safety [ Time Frame: Eight months ]

Enrollment:	387
Study Start Date:	January 1999
Study Completion Date:	July 2001

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490191

Show 26 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Study ID Numbers:	2073, B9R-EW-T002
Study First Received:	June 20, 2007
Last Updated:	June 20, 2007
ClinicalTrials.gov Identifier:	NCT00490191
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dwarfism
Bone Diseases, Endocrine
Hypopituitary dwarfism
Hypothalamic Diseases
Pituitary Diseases
Central Nervous System Diseases
Endocrine System Diseases
Dwarfism, Pituitary

Brain Diseases
Bone Diseases
Growth hormone deficiency
Body Weight
Hypopituitarism
Musculoskeletal Diseases
Bone Diseases, Developmental
Endocrinopathy

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009