Growth Hormone Therapy for Wasting in Cystic Fibrosis
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|ClinicalTrials.gov Identifier: NCT00803179|
Recruitment Status : Terminated (Poor enrollment, patients were lost to follow up)
First Posted : December 5, 2008
Results First Posted : January 15, 2013
Last Update Posted : January 15, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: Nutropin AQ||Phase 1|
The following is a more detailed description of the aims listed above:
Specific Aim 1: Measure change in weight in adults with CF related wasting following GH therapy.
1.1) Monitor weight gained or loss from baseline. 1.2) Assess changes in fat free mass from baseline by bioelectrical impedence analysis.
Specific Aim 2: Evaluate overall quality of life (QOL) in adults with CF related wasting treated with GH therapy.
2.1) Perform CF disease-specific and general QOL analysis via CF QOL questionnaires.
2.2) Monitor compliance with therapy via subject report.
Specific Aim 3: Monitor impact of GH therapy in relation to CF related diabetes onset or control.
3.1) Measure impact on insulin sensitivity in non-diabetes subjects 3.2) Observe change in exogenous insulin requirements and glycemic control in subjects with diabetes.
Specific Aim 4: Quantify impact of anabolic therapy on manifestations of underlying diagnosis associated with CF.
4.1) Observe changes in lung function from baseline during GH therapy. 4.2) Determine changes in overall muscle strength via hand grip and six minute walk.
4.3) Evaluate changes in serum markers.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Growth Hormone Therapy for Wasting in Cystic Fibrosis|
|Study Start Date :||November 2008|
|Primary Completion Date :||March 2012|
|Study Completion Date :||March 2012|
U.S. FDA Resources
Experimental: Growth Hormone Therapy
Nutropin Aqueous (AQ):
Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d
Drug: Nutropin AQ
Based on recommendations from the 2007 GH Deficiency Consensus Workshop on adult GH deficiency, the recommended initiation of treatment for adult males is 0.2mg/d and for women 0.4mg/d, with a titration upwards based on insulin-like growth factor (IGF-1) (product of GH stimulation at target tissues) levels and patient response. IGF-1 will be monitored at the 3,4,5 and 11 month intervals. For subjects under the age of 25 with an open epiphysis of the hand and/or wrist we will treat with the dose of 0.3mg/kg/week. Subjects will be on growth hormone for 8 months with a baseline visit prior to initiation of therapy and a 3 month follow-up visit after stopping therapy.
Other Name: Growth Hormone (GH)
- Measure Change in Weight in Adults With Cystic Fibrosis (CF) Related Wasting Following Growth Hormone (GH) Therapy [ Time Frame: 14 months ]
- Evaluate Overall Quality of Life (QOL) in Adults With CF Related Wasting Treated With GH Therapy [ Time Frame: 14 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803179
|United States, Massachusetts|
|Worcester, Massachusetts, United States, 01655|
|Principal Investigator:||Michael Stalvey, MD||Unversity of Massachusetts Medical School|