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Open-label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis

Phase 4
Completed
Conditions
Prostate Cancer
Registration Number
NCT00035997
Lead Sponsor
Novartis Pharmaceuticals
Brief Summary

The purpose of this trial with Zometa is to investigate the effect ZOMETA 4 mg (zoledronic acid for injection in 100mg solution ) has in preventing associated bone loss in prostate cancer patients with bone metastasis when administered in conjunction with hormonal cancer therapy. This trial will seek to determine the effect of ZOMETA in stabilizing and increasing bone mineral density in these patients.

This prospective, open-label, single arm, multicenter study will enroll approximately 200 prostate cancer patients with a history of at least one documented bone lesion documented by bone scan or radiograph. Patients must already be receiving hormone therapy and meet the following additional criteria:

* 18 years of age or older

* Histologically confirmed diagnoses of prostate cancer

* Confirmed objective evidence of metastatic bone disease as evidenced by bone scan or radiograph

* Received or will receive hormonal treatment also know as androgen deprivation therapy with an LHRH agonist or other hormonal treatments

Throughout the course of this 12-month trial, patients will be identified based on the duration of established hormonal treatment at the time of enrollment. Each patients duration of participation will be up to 56 weeks including a 4 week screening, 48 week treatment and a 4 week follow up.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
261
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Changes in bone mineral density of the lumbar spine (L2-L4) at 12 months
Secondary Outcome Measures
NameTimeMethod
Changes in biochemical markers of bone turnover over 12 months
Changes in bone mineral density of the total hip at 12 months
Time to first skeletal-related event
Overall safety measured by adverse events (AEs)

Trial Locations

Locations (56)

Norwood Clinic

🇺🇸

Birmingham, Alabama, United States

Alaska Clinical Research Center, LLC

🇺🇸

Anchorage, Alaska, United States

Advanced Urology Medical Center

🇺🇸

Anaheim, California, United States

Urology Associates of Central CA

🇺🇸

Fresno, California, United States

Center for Urological Research

🇺🇸

La Mesa, California, United States

Atlantic Urological Medical Group

🇺🇸

Long Beach, California, United States

Advanced Urology Medical Offices

🇺🇸

Los Angeles, California, United States

Advanced Urology Medical Office

🇺🇸

Los Angeles, California, United States

Boulder Medical Center

🇺🇸

Boulder, Colorado, United States

Urology Associates, P.C.

🇺🇸

Denver, Colorado, United States

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Norwood Clinic
🇺🇸Birmingham, Alabama, United States

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