HORMA: Hormonal Regulators of Muscle and Metabolism in Aging
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|ClinicalTrials.gov Identifier: NCT00183040|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 2, 2009
|Condition or disease||Intervention/treatment||Phase|
|Sarcopenia Muscle Weakness Frailty||Drug: Topical testosterone Drug: Recombinant human growth hormone||Phase 2|
Elderly persons experience progressive loss of skeletal muscle mass, muscle strength, and functional capacity for activities of daily living. Aging is also associated with a loss of hormones believed to be related to muscle and strength, namely testosterone and growth hormone (GH). The hypothesis being tested is that both hormone systems regulate musculoskeletal protein mass and contractile fibers by different and complimentary mechanisms and that optimal levels of both testosterone and GH are necessary to maintain skeletal muscle mass, muscular strength and power, and full functional activities of daily living during the aging process.
This is a controlled, 16 week study to evaluate the independent effects and interaction of these two anabolic hormone systems in community dwelling elderly men 65-90 years of age who are hyposomatotropic (deficiency of growth hormone) with low eugonadal status (total testosterone of 150-550 ng/dL). The study will utilize a two tiered randomization in which 108 study participants will first be randomized to either the low or high eugonadal level of testosterone using a novel Leydig cell clamp method (GnRH (gonadotropin-releasing hormone) agonist plus topical testosterone supplementation) to achieve target levels of testosterone. Low gonadal status (150-550 ng/dL) will be maintained with 5 g daily doses of topical testosterone, whereas high gonadal status (650-950 ng/dL) will be achieved with 10 g daily doses. Within these two groups, participants will be randomized to receive placebo or one of two doses of rhGH (recombinant human growth hormone) therapy (0, 3.0, 5.0 mcg/kg/day) in a double blinded fashion.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Hormonal Regulators of Muscle and Metabolism in Aging|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||February 2007|
- measures of fractional synthetic rates of mixed and contractile (actin and myosin heavy chain [MHC]) skeletal muscle proteins and degradation of skeletal muscle (ubiquitin, and proteasome sub-units)
- analysis of local regulators of skeletal muscle synthesis (e.g. IGF-1, IGFBP4, myostatin).
- change in skeletal muscle strength, muscle mass, power and fatigability (endurance), physical performance, and markers of safety.
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): NCT00183040
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02111|
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63108|
|Principal Investigator:||Fred R. Sattler, MD||Keck School of Medicine, University of Southern California|