Growth Hormone Use in Adolescents and Adults With Cystic Fibrosis

This study is ongoing, but not recruiting participants.

First Received: February 2, 2006 No Changes Posted

Sponsored by:	University of Texas Southwestern Medical Center
Information provided by:	University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:	NCT00287430

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)

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

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:

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

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

Study placed in the following topic categories:

Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis
Hormone Antagonists

Lung Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Infant, Newborn, Diseases
Pancreatic Diseases
Hormones

Additional relevant MeSH terms:

Fibrosis
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions
Digestive System Diseases
Pathologic Processes

Cystic Fibrosis
Respiratory Tract Diseases
Genetic Diseases, Inborn
Lung Diseases
Pancreatic Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on May 07, 2009