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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00490191
First received: June 20, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Dwarfism, Pituitary
Hypopituitarism
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014