Testosterone and Growth Hormone for Bone Loss in Men

June 12, 2014 updated by: Peter Snyder, University of Pennsylvania

Will Testosterone and Growth Hormone Improve Bone Structure?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, one year, two years

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

  • Principal Investigator: Peter J. Snyder, MD, University of Pennsylvania
  • Principal Investigator: Cecilia Lansang, MD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

April 5, 2004

First Submitted That Met QC Criteria

April 5, 2004

First Posted (Estimate)

April 6, 2004

Study Record Updates

Last Update Posted (Estimate)

June 13, 2014

Last Update Submitted That Met QC Criteria

June 12, 2014

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AR050618 (U.S. NIH Grant/Contract)
  • NIAMS-118

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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