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Testosterone and Growth Hormone for Bone Loss in Men

NCT00080483 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2014-06-13

Study results available
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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.

Conditions

  • Hypopituitarism
  • Hypogonadism
  • Growth Hormone Deficiency

Interventions

DRUG

Testosterone plus somatropin

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

DRUG

testosterone

AndroGel transdermally 5 g a day for two years

Sponsors & Collaborators

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

    collaborator NIH

  • University of Pennsylvania

    lead OTHER

Principal Investigators

  • Peter J. Snyder, MD · University of Pennsylvania

  • Cecilia Lansang, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00080483 on ClinicalTrials.gov