Trial record 19 of 237 for:    "combined pituitary hormone deficiency" OR "Hypopituitarism"

Testosterone and Growth Hormone for Bone Loss in Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00080483
Recruitment Status : Completed
First Posted : April 6, 2004
Results First Posted : June 13, 2014
Last Update Posted : June 13, 2014
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Peter Snyder, University of Pennsylvania

Brief Summary:
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 or disease Intervention/treatment Phase
Hypopituitarism Hypogonadism Growth Hormone Deficiency Drug: Testosterone plus somatropin Drug: testosterone Phase 2

Detailed Description:

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Will Testosterone and Growth Hormone Improve Bone Structure?
Study Start Date : March 2004
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Arm Intervention/treatment
Experimental: 1
Testosterone transdermally 5 g a day and somatropin subcutaneously 2 µg/kg body weight a day
Drug: Testosterone plus somatropin
AndoGel 5 grams transdermally a day for two years Somatropin 2 µg/kg body weight/day for two years
Active Comparator: 2
AndroGel transdermally 5 g a day for two years
Drug: testosterone
AndroGel transdermally 5 g a day for two years

Primary Outcome Measures :
  1. MicroMRI-derived Structural (Bone Volume Fraction-BVF) of the Distal Tibia at Baseline and After One and Two Years of Treatment. [ Time Frame: baseline, one year, two years ]
    Increased bone volume fraction (the fraction of bone that is bone, as opposed to the fraction that is marrow), as determined by magnetic resonance of the distal tibia

Other Outcome Measures:
  1. Increased Trabecular Thickness, as Determined by Magnetic Resonance of the Distal Tibia [ Time Frame: 2 years ]
  2. Improved Architectural Parameters of Trabecular Bone Reflecting Connectivity, as Determined by Magnetic Resonance Imaging [ Time Frame: 2 years ]
  3. Increased Cortical Thickness and Cortical Density, as Determined by Peripheral Quantitative Computed Tomography of the Tibial Metaphysis [ Time Frame: 2 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Documented hypothalamic or pituitary hormone deficiency
  • Testosterone deficiency, defined as total serum testosterone less than 250 ng/dL at two 8 AM readings
  • Growth hormone deficiency, defined by either of the following:
  • For subjects who have thyroxine and cortisol deficiencies, either a subnormal age-specific IGF-1 or a peak GH response to arginine-GHRH of less than 4.1 ng/mL
  • For subjects who do not have thyroxine and cortisol deficiencies, either a subnormal age-specific IGF-1 or a peak GH response to arginine-GHRH of less than 4.1 ng/mL
  • Duration of testosterone and growth hormone deficiencies of two years or more
  • Replacement of cortisol and/or thyroxine deficiencies
  • Able to give informed consent

Exclusion Criteria:

  • Current testosterone treatment or treatment during the two years prior to study entry
  • Current growth hormone treatment or treatment during the three years prior to study entry
  • Use of other prescription or over-the-counter androgens (androstenedione, DHEA), estrogens, or antiandrogens (spironolactone, ketoconazole)
  • Diseases that could influence bone, such as hyperparathyroidism
  • Medications that could influence bone, such as anticonvulsants or glucocorticoids (prednisone greater than 20 mg/day for longer than 2 weeks/year). Calcium and over-the-counter vitamin D supplements are allowed.
  • Cancer that could limit life expectancy to fewer than 5 years
  • Neuromuscular disease or history of stroke with residual neurological defect
  • Severe or uncontrolled psychiatric illness or dementia
  • Noncancerous enlargement of the prostate gland (American Urological Association symptom score greater than 21)
  • Prostate cancer by history, prostate nodule on digital rectal exam (DRE), or prostate specific antigen (PSA) greater than 4
  • Current alcohol or drug dependence
  • Heart failure (New York class III or IV)
  • Unstable angina
  • Myocardial infarction within 3 months of study entry
  • Liver disease (ALT greater than 3 x normal)
  • Renal disease (serum creatinine greater than 2.5 mg/dl)
  • Diabetes mellitus (glycosolated hemoglobin greater than 8.0%)
  • Hypertension (systolic BP greater than 160 or diastolic BP greater than 100 mm Hg)
  • Hematocrit greater than 48%
  • Weight greater than 300 pounds
  • Poor quality scan at baseline even when repeated
  • Untreated, severe, obstructive sleep apnea (Epworth sleepiness score greater than 10)
  • Unable to undergo an MRI because of a cardiac pacemaker or ferrometallic objects in the body

Information from the National Library of Medicine

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 identifier (NCT number): NCT00080483

United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Peter J. Snyder, MD University of Pennsylvania
Principal Investigator: Cecilia Lansang, MD University of Florida

Publications of Results:
Responsible Party: Peter Snyder, Professor of Medicine, University of Pennsylvania Identifier: NCT00080483     History of Changes
Other Study ID Numbers: R01AR050618 ( U.S. NIH Grant/Contract )
R01AR050618 ( U.S. NIH Grant/Contract )
First Posted: April 6, 2004    Key Record Dates
Results First Posted: June 13, 2014
Last Update Posted: June 13, 2014
Last Verified: December 2013

Additional relevant MeSH terms:
Dwarfism, Pituitary
Gonadal Disorders
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents