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Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00080483 |
Deficiency of testosterone, growth hormone, or both hormones can result in osteoporosis. If either hormone is replaced, the condition of the bones improves. The purpose of this study is to determine if dual hormone treatment for men deficient in testosterone and growth hormone improves bone structure more than testosterone treatment alone.
Condition | Intervention |
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Hypopituitarism Hypogonadism Growth Hormone Deficiency |
Drug: Testosterone plus somatropin Drug: testosterone |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Will Testosterone and Growth Hormone Improve Bone Structure? |
Estimated Enrollment: | 40 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Testosterone transdermally 5 g a day and somatropin subcutaneously 2 µg/kg body weight a day
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Drug: Testosterone plus somatropin
AndoGel 5 grams transdermally a day for two years Somatropin 2 µg/kg body weight/day for two years
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2: Active Comparator
AndroGel transdermally 5 g a day for two years
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Drug: testosterone
AndroGel transdermally 5 g a day for two years
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Replacement of testosterone or growth hormone in patients who are deficient improves osteoporosis associated with these deficiencies. In some tissues, such as muscle, the effects of testosterone and growth hormone are additive, but it is not known if the effects are additive in bone as well. This study will compare the effects of testosterone alone with testosterone plus growth hormone in improving bone structure in men with total pituitary hormone deficiency.
Participants in this study will be men who have pituitary or hypothalamic disease and have deficiencies of all pituitary hormones, but who have not been treated with either testosterone or growth hormone. The men will be randomly assigned to receive either testosterone alone or testosterone plus growth hormone for two years. Testosterone in a gel form will be applied daily to the skin. Growth hormone will be self-administered by daily subcutaneous injection. Blood concentrations of both hormones will be monitored with blood tests every 3 months during the 2-year study. Doses of the hormones will be adjusted to keep blood concentrations of the hormones within the normal range. Changes in bone structure will be assessed noninvasively before treatment and after one year and two years of treatment by magnetic resonance microimaging (µMRI) and dual energy X-ray absorptiometry (DEXA).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Peter J. Snyder, MD | University of Pennsylvania |
Principal Investigator: | Laurence Kennedy, MD | University of Pennsylvania |
Responsible Party: | University of Pennsylvania ( Peter J. Snyder, MD Professor of Medicine ) |
Study ID Numbers: | NIAMS-118, RO1 AR050618-01 |
Study First Received: | April 5, 2004 |
Last Updated: | November 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00080483 |
Health Authority: | United States: Federal Government |
Dwarfism Bone Diseases, Endocrine Hypopituitary dwarfism Hypothalamic Diseases Pituitary Diseases Gonadal Disorders Central Nervous System Diseases Endocrine System Diseases Methyltestosterone Dwarfism, Pituitary |
Brain Diseases Bone Diseases Growth hormone deficiency Testosterone 17 beta-cypionate Testosterone Hypogonadism Hypopituitarism Musculoskeletal Diseases Bone Diseases, Developmental Endocrinopathy |
Anabolic Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Nervous System Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions Androgens |