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Home > "G" Clinical Trials Conditions > Growth Hormone Use in Cystic Fibrosis - a Multicenter Study  Growth Hormone Use in Cystic Fibrosis - a Multicenter Study
Growth Hormone Use in Cystic Fibrosis - a Multicenter Study
For Condition: Cystic Fibrosis
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Genentech
Synopsis: Cystic Fibrosis (CF) is the most common lethal genetic disorder in America. Previous studies by our group and others have shown that human recombinant growth hormone (GH) improves height velocity, weight velocity, lean body mass (LBM) and pulmonary function. These positive results have prompted us to ask further questions regarding GH use in CF including: a) Do patients with better baseline body weight and pulmonary function derive more benefit from treatment than those with worse weight and pulmonary function?, b) Does GH use improve the patient's quality of life?, c) Once GH is discontinued, are the positive effects sustained? We hypothesize that GH treatment in CF patients will improve their clinical status and their quality of life. We further hypothesize that these effects will be present regardless of baseline body weight or pulmonary function, and that positive outcome will be sustained for at least one year after GH treatment is discontinued. To test our hypothesis, we will recruit 40 prepubertal children from five CF centers across the United States (8 per center). Patients will be randomly assigned to receive treatment with GH (0.3mg/kg/wk) during either the first or the second year. All subjects will be seen every three months. We will evaluate the following parameters every three months: 1) height, height velocity and Z-score, 2) body weight and weight velocity. Every six months we will measure: 1) lean body mass utilizing DEXA, 2) pulmonary function, including measurement of respiratory muscle strength (peak inspiratory and peak expiratory pressure), 3) quality of life (QOL), quantitated from QOL forms specific for CF ("The Cystic Fibrosis Questionnaire"). After one year of study, subjects will "cross-over" to the other treatment arm. This 24 month study will allow us to statistically compare outcome measures in 20 treated and 20 nontreated subjects from multiple centers, and will allow us to assess sustained effect in the 20 subjects who receive GH during the first year, by comparing their results to results obtained during the year post treatment.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized
Minimum Age/Maximum Age: 5 Years/12 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - CF patients ages 5-12 who are less than the 25th percentile for age and sex normal values for height and/or weight
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DanaHardin, Principal Investigator,
University of Utah, Dept of Pediatric Endocrinology
Salt Lake City, Utah, 84132
United States
University of Texas Medical School
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: NCRR-M01RR02558-0111; M01RR02558
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005112
Other Cystic Fibrosis Studies:
1. Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis
2. Bone Health of People with Cystic Fibrosis
3. Study of Hepatic Glucose Production and De novo Lipogenesis in Patients With Cystic Fibrosis
4. A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children with Cystic Fibrosis
5. Pressure support ventilation during CF exacerbations
Related Studies:
Other Cystic Fibrosis Clinical Trials
Other Utah Clinical Trials
Other Salt Lake City Clinical Trials
Growth Hormone Use in Cystic Fibrosis - a Multicenter Study
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