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
Public ClinicalTrials.gov record NCT00035997. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00035997
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 261 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2002
- Primary completion
- Dec 31, 2003
- Completion
- Dec 31, 2003
- Last update posted
- Nov 22, 2009
2002 – 2004
United States locations
- U.S. sites
- 56
- U.S. states
- 22
- U.S. cities
- 53
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Norwood Clinic | Birmingham | Alabama | 35234 | — |
| Alaska Clinical Research Center, LLC | Anchorage | Alaska | 99508 | — |
| Advanced Urology Medical Center | Anaheim | California | 92801 | — |
| Urology Associates of Central CA | Fresno | California | 93720 | — |
| Center for Urological Research | La Mesa | California | 91942 | — |
| Atlantic Urological Medical Group | Long Beach | California | 90806 | — |
| Advanced Urology Medical Offices | Los Angeles | California | 90045 | — |
| Advanced Urology Medical Office | Los Angeles | California | 90045 | — |
| Boulder Medical Center | Boulder | Colorado | — | — |
| Urology Associates, P.C. | Denver | Colorado | 80210 | — |
| Atlantic Urological Associates | Daytona Beach | Florida | 32114 | — |
| Southwest Florida Urologic Association | Fort Myers | Florida | — | — |
| Diagnostic Clinic | Largo | Florida | 33770 | — |
| DMI Health Care Group, Inc. | Largo | Florida | 33773 | — |
| Marvin Stein, MD | Margate | Florida | 33063 | — |
| Miami Cancer Institute | Miami | Florida | 33143 | — |
| Advanced Research Institute | New Port Richey | Florida | 34652 | — |
| Florida Foundation for Healthcare Research | Ocala | Florida | 34474 | — |
| Urology Associates of Northeast Florida, PA | Orange Park | Florida | 32073 | — |
| Winter Park Urology Associates | Orlando | Florida | 32803 | — |
| Pinellas Urology, Inc. | St. Petersburg | Florida | 33710 | — |
| Southeastern Urological Center | Tallahassee | Florida | 32308 | — |
| Georgia Urology Research Institute | Atlanta | Georgia | 30342 | — |
| Ball Memorial Hospital | Muncie | Indiana | 47303 | — |
| Urological Associates PC | Davenport | Iowa | 52807 | — |
| Drs. Werner, Murdock and Francis PA Urology Associates | Greenbelt | Maryland | 20770 | — |
| Urology Associates of Middlesex County, Inc. | Marlborough | Massachusetts | 01752 | — |
| Lakeside Urology, P.C. | Saint Joseph | Michigan | 49085 | — |
| Millennium Medical Center | Southfield | Michigan | 48075 | — |
| Kansas City Urology Care | Kansas City | Missouri | 64131 | — |
| The Prostate Center of Greater St. Louis | St Louis | Missouri | 63136 | — |
| American Academy of Urology | Las Vegas | Nevada | 89119 | — |
| Urological Surgical Associates | Edison | New Jersey | — | — |
| UroResearch, LLC | Morristown | New Jersey | 07960 | — |
| Shaukat M. Qureshi, MD | Pennsville | New Jersey | 08070 | — |
| Urology Associates | Stratford | New Jersey | — | — |
| Associates in Urology, LLC | West Orange | New Jersey | 07052 | — |
| AccuMed Research Associates | Garden City | New York | 11530 | — |
| Urological Surgeons of Long Island PC | Garden City | New York | 11530 | — |
| Kingston Urological Assoc. | Kingston | New York | 12401 | — |
| Cary Urology, P.A. | Cary | North Carolina | 27511 | — |
| Matrix Research, LLC | Greenville | North Carolina | 29607 | — |
| The Urology Group | Cincinnati | Ohio | 45212 | — |
| Southwest Urology | Parma | Ohio | 44129 | — |
| Roger N. Andrews, MD Inc. | Arcadia | Pennsylvania | 91007 | — |
| Urologic Surgery, PC | Bala-Cynwyd | Pennsylvania | 19004 | — |
| James W. Thompson, MD Ltd. | Bryn Mawr | Pennsylvania | 09010 | — |
| Urology Institute of Pittsburgh | Monroeville | Pennsylvania | 15146 | — |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | — |
| Center for Urologic Care of Berks County | West Reading | Pennsylvania | 19611 | — |
| Grand Strand Urology | Myrtle Beach | South Carolina | 29572 | — |
| Urology Center of the South P.C. | Germantown | Tennessee | 38138 | — |
| Murfreesboro Medical Clinic | Murfreesboro | Tennessee | 37130 | — |
| Urology Associates, PA | Nashville | Tennessee | 37209 | — |
| Research Across America | Carrollton | Texas | 75010 | — |
| CAMC Clinical Trials | Charleston | West Virginia | 25304 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00035997, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 22, 2009 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00035997 live on ClinicalTrials.gov.