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Zometa on Bone Mineral Density in Prostate Cancer Patients Undergoing Androgen Ablation Therapy

NCT00582556 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2019-11-26

Study results available
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Summary

The purpose of this research is to determine the effect of timing of Zometa® administration on bone mineral density of the lumbar spine and femoral neck in men undergoing androgen deprivation therapy for prostate adenocarcinoma. In addition, the researchers will also determine the effects of treatment with Zometa® on peripheral blood markers of bone turnover, on peripheral blood gd T-cell frequencies and function, and to determine if the above treatments elicit prostate antigen-specific IgG immune responses. The effects of the above treatments on serial serum PSA measurements will also be examined.

Conditions

Interventions

DRUG

Zometa

GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy

DRUG

zometa

GnRH analogue 3-mo depot - q3 months for 1 yr andZometa 4 mg IV over 15 min x 1, given at mo 6

DRUG

Zometa

GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.

Sponsors & Collaborators

Principal Investigators

  • Douglas McNeel, MD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2011-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT00582556 on ClinicalTrials.gov