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Growth Hormone Use in Adolescents and Adults With Cystic Fibrosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by University of Texas Southwestern Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00287430
First received: February 2, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

We hypothesize that the anabolic effects of growth hormone (GH) will improve the clinical status of patients with CF by improving lean body mass, osteopenia, muscle strength, pulmonary function, and quality of life.

We will recruit 40 malnourished CF patients for this 12-month study. All 40 patients will be treated with recombinant human growth hormone (rhGH). Each patient will serve as his/her own control by obtaining medical records for 6 months to 1 year prior to study enrollment or by completing 6 months of study without GH prior to being treated for 1 yr. with GH.


Condition Intervention
Cystic Fibrosis
 Drug: Growth Hormone
Procedure: Whole body Protein Turnover Study
Procedure: Dual Energy X-ray Absorptiometry (DEXA)

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

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 1) body weight
  • 2) lean body mass.

Secondary Outcome Measures:
  • 1) whole body protein turnover
  • 2) hepatic glucose production
  • 3) bone mineral density
  • 4) pulmonary function status
  • 5) quality of life

Estimated Enrollment: 12
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 6 - 40 years
  • less than 100% of ideal body weight.

Exclusion Criteria:

  • Colonization with Burkholderia cepacia
  • pregnancy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287430

Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Dana S Hardin, MD University of Texas Southwestern Medical Center at Dallas
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00287430     History of Changes
Other Study ID Numbers: 0102-035
Study First Received: February 2, 2006
Last Updated: February 2, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
 Infant, Newborn, Diseases
Pathologic Processes
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013