Trial · Interventional

CompletedPhase 2Results postedRegistry data

Testosterone and Growth Hormone for Bone Loss in Men

NCTNCT00080483Other idR01AR050618Other idR01AR050618Other idNIAMS-118

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Overview

Status: Completed
Phase: Phase 2
Enrollment: 35 participants (actual)
Sponsor: University of Pennsylvania · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Mar 2004
Primary completion: Sept 2010
Completion: Sept 2010
First posted: 6 Apr 2004 (estimated)
Last update posted: 13 Jun 2014 (estimated)
Conditions: Hypopituitarism · Hypogonadism · Growth Hormone Deficiency

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2004200620082010

Ph 2
Testosterone and Growth Hormone for Bone Loss in Men
NCT00080483
Mar 2004 to Sept 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Testosterone plus somatropinDrug
testosteroneDrug

Arms2

Experimental
1
Testosterone transdermally 5 g a day and somatropin subcutaneously 2 µg/kg body weight a day
Active comparator
2
AndroGel transdermally 5 g a day for two years

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Registry description
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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· baseline, one year, two years

MicroMRI-derived Structural (Bone Volume Fraction-BVF) of the Distal Tibia at Baseline and After One and Two Years of Treatment.

Group	Value (unitless)	Spread
1 The Effects of Testosterone Combined With G	0.112	0.004
2 The Effects of Testosterone Alone on Structural and Mechanic	0.104	0.004

Secondary and other outcome results(3)

Other pre specified outcome· 2 years

Increased Trabecular Thickness, as Determined by Magnetic Resonance of the Distal Tibia

Group	Value

Other pre specified outcome· 2 years

Improved Architectural Parameters of Trabecular Bone Reflecting Connectivity, as Determined by Magnetic Resonance Imaging

Group	Value

Other pre specified outcome· 2 years

Increased Cortical Thickness and Cortical Density, as Determined by Peripheral Quantitative Computed Tomography of the Tibial Metaphysis

Group	Value

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
1Testosterone OnlyTestosterone transdermally 5 g a day	–	4 / 17	10 / 17
2Testosterone Plus Growth HormoneAndroGel transdermally 5 g a day somatropin subcutaneously 2 µg/kg body weight a day	–	4 / 18	11 / 18

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

ResultAl Mukaddam M, Rajapakse CS, Bhagat YA, Wehrli FW, Guo W, Peachey H, LeBeau SO, Zemel BS, Wang C, Swerdloff RS, Kapoor SC, Snyder PJ. Effects of testosterone and growth hormone on the structural and mechanical properties of bone by micro-MRI in the distal tibia of men with hypopituitarism. J Clin Endocrinol Metab. 2014 Apr;99(4):1236-44. doi: 10.1210/jc.2013-3665. Epub 2014 Jan 13. PMID 24423356

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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