Completed

Will Testosterone and Growth Hormone Improve Bone Structure?

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What is being tested

Testosterone plus somatropin

+ testosterone

Drug
Who is being recruted

Bone Diseases+12

+ Bone Diseases, Developmental

+ Bone Diseases, Endocrine

Over 18 Years
+31 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorUniversity of Pennsylvania
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2004

Actual date on which the first participant was enrolled.

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).

Official TitleWill Testosterone and Growth Hormone Improve Bone Structure?
NCT00080483
Principal SponsorUniversity of Pennsylvania
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

35 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone DiseasesBone Diseases, DevelopmentalBone Diseases, EndocrineBrain DiseasesCentral Nervous System DiseasesDwarfismDwarfism, PituitaryEndocrine System DiseasesGonadal DisordersHypogonadismHypopituitarismHypothalamic DiseasesMusculoskeletal DiseasesNervous System DiseasesPituitary Diseases

Criteria

8 inclusion criteria required to participate
Able to give informed consent
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:
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23 exclusion criteria prevent from participating
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
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

Active Comparator
AndroGel transdermally 5 g a day for two years

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hospital of the University of Pennsylvania

Philadelphia, United StatesOpen Hospital of the University of Pennsylvania in Google Maps
CompletedOne Study Center