NCT00080483

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 5, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2004

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

June 13, 2014

Completed
Last Updated

June 13, 2014

Status Verified

December 1, 2013

Enrollment Period

6.5 years

First QC Date

April 5, 2004

Results QC Date

December 12, 2013

Last Update Submit

June 12, 2014

Conditions

HypopituitarismHypogonadismGrowth Hormone Deficiency

Outcome Measures

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

    baseline, one year, two years

Other Outcomes (3)

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

    2 years

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

    2 years

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

    2 years

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Testosterone plus somatropin

2

ACTIVE COMPARATOR

AndroGel transdermally 5 g a day for two years

Drug: testosterone

Interventions

Testosterone plus somatropinDRUG

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

1
testosteroneDRUG

AndroGel transdermally 5 g a day for two years

2

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 24423356RESULT

MeSH Terms

Conditions

HypopituitarismHypogonadismDwarfism, Pituitary

Interventions

TestosteroneHuman Growth Hormone

Condition Hierarchy (Ancestors)

Pituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesGonadal DisordersDwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, Endocrine

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsGrowth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Peter J. Snyder M.D.
Organization
University of Pennsylvania
pjs@mail.med.upenn.edu
215-898-0208

Study Officials

  • Peter J. Snyder, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Cecilia Lansang, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

April 5, 2004

First Posted

April 6, 2004

Study Start

March 1, 2004

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

June 13, 2014

Results First Posted

June 13, 2014

Record last verified: 2013-12

Locations

US(1)