HypopituitarismPhase 2NCT00080483

Testosterone and Growth Hormone for Bone Loss in Men

A Phase 2 study testing Testosterone plus somatropin and testosterone in people with Hypopituitarism and Hypogonadism, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Hypopituitarism, Hypogonadism, Growth Hormone Deficiency
What is being tested?: Testosterone plus somatropin and testosterone
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: Mar 2004to Sep 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 23Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Will Testosterone and Growth Hormone Improve Bone Structure?

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).

Conditions: Hypopituitarism, Hypogonadism, Growth Hormone Deficiency
Being tested: Testosterone plus somatropin, testosterone
Medical subject headings: Hypopituitarism, Hypogonadism, Dwarfism, Pituitary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Testosterone plus somatropinDrug
AndoGel 5 grams transdermally a day for two years Somatropin 2 µg/kg body weight/day for two years
testosteroneDrug
AndroGel transdermally 5 g a day for two years

Study groups in NCT00080483
Study group	Role	What they receive
1	Experimental	Testosterone transdermally 5 g a day and somatropin subcutaneously 2 µg/kg body weight a day Receives: Drug: Testosterone plus somatropin
2	Active comparator	AndroGel transdermally 5 g a day for two years Receives: Drug: testosterone

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: baseline, one year, two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2004Sep 2010

First posted6 Apr 2004 (estimated)
Study startMar 2004
Primary completionSep 2010
Study completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypopituitarismStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00080483
Sponsor's protocol ID: R01AR050618
Other IDs: R01AR050618, NIAMS-118
Status last verified: Dec 2013
First submitted: 5 Apr 2004
Last updated: 13 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
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RecruitingPhase 3
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RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
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Active, not recruitingObservational study
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All Hypopituitarism trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Will Testosterone and Growth Hormone Improve Bone Structure?
ClinicalTrials.gov ID: NCT00080483
Acronym / sponsor ID: R01AR050618
Conditions: Hypopituitarism, Hypogonadism, Growth Hormone Deficiency
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study start: Mar 2004
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 6 Apr 2004 (estimated)
Results: Posted 13 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Testosterone plus somatropinTestosterone transdermally 5 g a day and somatropin subcutaneously 2 µg/kg body weight a day
2	Active comparator	Drug: testosteroneAndroGel transdermally 5 g a day for two years

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (23 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Testosterone plus somatropinAndoGel 5 grams transdermally a day for two years Somatropin 2 µg/kg body weight/day for two years	Drug	1
testosteroneAndroGel transdermally 5 g a day for two years	Drug	2

Primary outcome

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

Results and safety

Results posted to the registry on 13 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1Testosterone Only	17	15
2Testosterone Plus Growth Hormone	18	16

Primary outcome: 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. Mean (Standard Error). Unit: unitless

Measure	1 The Effects of Testosterone Combined With G n = 17	2 The Effects of Testosterone Alone on Structural and Mechanic n = 15
baseline	0.112 (0.004)	0.104 (0.004)
one year	0.119 (0.004)	0.111 (0.006)
two years	0.123 (0.005)	0.114 (0.005)

Population analysed: All subjects who had both baseline and one year evaluations

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1Testosterone Only	4 of 17 (23.5%)	10 of 17 (58.8%)	Not reported
2Testosterone Plus Growth Hormone	4 of 18 (22.2%)	11 of 18 (61.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24423356Al 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.

Related trials for Hypopituitarism

RecruitingPhase 1
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
Vasopressin Deficiency
RecruitingEarly Phase 1
Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
Arginine Vasopressin Deficiency, Oxytocin Deficiency
RecruitingPhase 3
Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
Growth Hormone Deficiency (GHD)
RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
Active, not recruitingObservational study
Ngenla Subcutaneous Injection Special Investigation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter J. Snyder, MD principal investigator

University of Pennsylvania

Cecilia Lansang, MD principal investigator

University of Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Testosterone plus somatropin and testosterone in people with Hypopituitarism and Hypogonadism, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00080483, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2014.