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Study of Adults With Low Growth Hormone Who Survived Childhood Cancer Where Treatment Caused Low Bone Density

NCT00145704 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2013-04-08

Study results available
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Summary

The purpose of this project is to evaluate the hypothesis that bisphosphonate treatment given to growth hormone deficient patients (regardless of current growth hormone replacement therapy status and without changing that status) significantly increases total body bone mineral density during an eighteen month period of treatment combined with calcium and Vitamin D when compared to calcium and Vitamin D treatment alone.

Conditions

  • Osteopenia

Interventions

DRUG

bisphosphonate therapy (risedronate)

Bisphosphonate therapy given to patients with growth hormone deficiency

DIETARY_SUPPLEMENT

Vitamin D supplement

Vitamin D given to patients with growth hormone deficiency

DIETARY_SUPPLEMENT

Calcium

calcium supplement given to patients with growth hormone deficiency

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • State University of New York - Upstate Medical University

    lead OTHER

Principal Investigators

  • Timothy A Damron, MD · State University of New York - Upstate Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

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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 NCT00145704 on ClinicalTrials.gov