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Sponsored by: |
Novartis Pharmaceuticals |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00035997 |
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:
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.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Zometa |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Trial on the Effect of I.V. Zoledronic Acid 4 mg on Bone Mineral Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis |
Enrollment: | 261 |
Study Start Date: | April 2002 |
Study Completion Date: | January 2004 |
Primary Completion Date: | January 2004 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Study Director: | Scott L. Pescatore, PharmD. | Novartis |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CZOL446EUS24, US24 |
Study First Received: | May 7, 2002 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00035997 |
Health Authority: | United States: Food and Drug Administration |
Hormone-sensitive Prostate Cancer Prostate Cancer Bone Metastasis |
Zoledronic acid Prostatic Diseases Genital Neoplasms, Male Neoplasm Metastasis |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes |
Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |