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CompletedNCT00080483Updated Jun 13, 2014Results posted

Testosterone and Growth Hormone for Bone Loss in Men

A Phase 2 interventional study of Testosterone plus somatropin and testosterone in Hypopituitarism, Hypogonadism and Growth Hormone Deficiency, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-13.

Sponsored by University of Pennsylvania · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the 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).

02

Conditions studied

  • Hypopituitarism
  • Hypogonadism
  • Growth Hormone Deficiency
03

In context

Hypopituitarism

43 studies on the registry are indexed under Hypopituitarism; 9 are open to participants now.

This study's enrollment of 35 is close to the median of 35 across 23 interventional studies indexed under Hypopituitarism.

Browse Hypopituitarism studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,664 studies on the registry; 236 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 107 (69%) have results posted.

Browse University of Pennsylvania studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    1

    Testosterone transdermally 5 g a day and somatropin subcutaneously 2 µg/kg body weight a day

    Drug: Testosterone plus somatropin

  • Active comparator
    2

    AndroGel transdermally 5 g a day for two years

    Drug: testosterone

Interventions

  • DrugTestosterone plus somatropin

    Drug pages: Testosterone · Human Growth Hormone

    AndoGel 5 grams transdermally a day for two years Somatropin 2 µg/kg body weight/day for two years

  • Drugtestosterone

    AndroGel transdermally 5 g a day for two years

06

What researchers measure

Primary outcomes

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

    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

    Time frame: baseline, one year, two years

Other outcomes

  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

07

Results

Posted Jun 13, 2014

Participant flow

This study was initiated in December, 2004 and enrollment ended in September 2008. Forty nine subjects were screened; 14 were screen failures and 35 subjects were randomized. Four subjects were withdrawn and 31 subjects completed the study.

Participant flow — Overall Study
Milestone1Testosterone Only2Testosterone Plus Growth Hormone
Started1718
Completed1516
Not completed22
Withdrew: Lost to follow-up11
Withdrew: Physician decision11

Outcome measures

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

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

Time frame:
baseline, one year, two years
Reported as:
Mean · unitless
MicroMRI-derived Structural (Bone Volume Fraction-BVF) of the Distal Tibia at Baseline and After One and Two Years of Treatment.
unitless1 The Effects of Testosterone Combined With G2 The Effects of Testosterone Alone on Structural and Mechanic
baseline0.112 ± 0.0040.104 ± 0.004
one year0.119 ± 0.0040.111 ± 0.006
two years0.123 ± 0.0050.114 ± 0.005
Other pre-specifiedIncreased Trabecular Thickness, as Determined by Magnetic Resonance of the Distal Tibia
Time frame:
2 years

Results for this outcome have not been posted.

Other pre-specifiedImproved Architectural Parameters of Trabecular Bone Reflecting Connectivity, as Determined by Magnetic Resonance Imaging
Time frame:
2 years

Results for this outcome have not been posted.

Other pre-specifiedIncreased Cortical Thickness and Cortical Density, as Determined by Peripheral Quantitative Computed Tomography of the Tibial Metaphysis
Time frame:
2 years

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
1Testosterone Only—4/17 (23.5%)10/17 (58.8%)
2Testosterone Plus Growth Hormone—4/18 (22.2%)11/18 (61.1%)
Most frequent serious events
Most frequent serious events
Event1Testosterone Only2Testosterone Plus Growth Hormone
cholycystitisGastrointestinal disorders1/170/18
coronary artery diseaseCardiac disorders1/170/18
sellar massNervous system disorders1/171/18
memory lossNervous system disorders1/170/18
arthritis of kneeMusculoskeletal and connective tissue disorders0/171/18
fractureMusculoskeletal and connective tissue disorders0/171/18
cancer of prostateReproductive system and breast disorders0/171/18
Most frequent other events
Showing 10 of 13
Most frequent other events
Event1Testosterone Only2Testosterone Plus Growth Hormone
upper respiratory infectionRespiratory, thoracic and mediastinal disorders0/177/18
positive Tinnel's signNervous system disorders0/174/18
hypothyroidEndocrine disorders2/173/18
anemiaBlood and lymphatic system disorders2/173/18
elevated PSAReproductive system and breast disorders1/173/18
tooth infectionInfections and infestations2/170/18
constipationGastrointestinal disorders2/171/18
nauseaGastrointestinal disorders2/170/18
urinary tract infectionRenal and urinary disorders2/170/18
fatigueGeneral disorders1/172/18

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)1Testosterone Only2Testosterone Plus Growth HormoneTotal
<=18 years000
Between 18 and 65 years141731
>=65 years314
Sex: Female, Male
Sex: Female, Male(Participants)1Testosterone Only2Testosterone Plus Growth HormoneTotal
Female000
Male171835
Region of Enrollment
Region of Enrollment(participants)1Testosterone Only2Testosterone Plus Growth HormoneTotal
United States171835
08

Study locations

1 site
  • Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
09

References and documents

Publications

  • Al 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. PubMed 24423356 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00080483
Lead sponsor
University of Pennsylvania
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Responsible party
Peter Snyder (Professor of Medicine, University of Pennsylvania) — Principal investigator
First posted
Apr 6, 2004
Start date
Mar 2004
Primary completion
Sep 2010
Completion
Sep 2010
Results posted
Jun 13, 2014
Last update
Jun 13, 2014

Study contacts

Peter J. Snyder, MD
principal investigator · University of Pennsylvania
Cecilia Lansang, MD
principal investigator · University of Florida

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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