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
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00035997
First received: May 7, 2002
Last updated: November 20, 2009
Last verified: November 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Zometa |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Changes in bone mineral density of the lumbar spine (L2-L4) at 12 months
Secondary Outcome Measures:
- 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)
| 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) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Signed informed consent
- Age > 18 years
- Histologically confirmed diagnosis of carcinoma of the prostate
- Objective evidence of metastatic disease to the bone as evidenced by bone scan or radiograph at any point since their diagnosis of prostate cancer
- Currently receiving, or will begin receiving, hormonal therapy with an LHRH agonist or other hormonal treatments for either < 6 months or > 6 months
- ECOG performance status of 0, 1, or 2
Exclusion criteria:
- Patients who are hormone sensitive without metastatic disease to the bone
- Patients who are hormone refractory typically defined as two or three consecutive increases in PSA measured at least one month apart while on hormone therapy
- Patients who are not treated with LHRH agonist or other hormonal treatments
- Patients who are currently receiving diethylstilbestrol (DES) or PC-SPES
- Patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol.
- Patients with abnormal renal function as evidenced by either a serum creatinine greater than 2 mg/dL or by a calculated creatinine clearance of 60 ml/minute or less
- Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035997
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Hide Study LocationsLocations
| United States, Alabama | |
| Norwood Clinic | |
| Birmingham, Alabama, United States, 35234 | |
| United States, Alaska | |
| Alaska Clinical Research Center, LLC | |
| Anchorage, Alaska, United States, 99508 | |
| United States, California | |
| Advanced Urology Medical Center | |
| Anaheim, California, United States, 92801 | |
| Urology Associates of Central CA | |
| Fresno, California, United States, 93720 | |
| Center for Urological Research | |
| La Mesa, California, United States, 91942 | |
| Atlantic Urological Medical Group | |
| Long Beach, California, United States, 90806 | |
| Advanced Urology Medical Office | |
| Los Angeles, California, United States, 90045 | |
| Advanced Urology Medical Offices | |
| Los Angeles, California, United States, 90045 | |
| United States, Colorado | |
| Boulder Medical Center | |
| Boulder, Colorado, United States | |
| Urology Associates, P.C. | |
| Denver, Colorado, United States, 80210 | |
| United States, Florida | |
| Atlantic Urological Associates | |
| Daytona Beach, Florida, United States, 32114 | |
| Southwest Florida Urologic Association | |
| Fort Myers, Florida, United States | |
| DMI Health Care Group, Inc. | |
| Largo, Florida, United States, 33773 | |
| Diagnostic Clinic | |
| Largo, Florida, United States, 33770 | |
| Marvin Stein, MD | |
| Margate, Florida, United States, 33063 | |
| Miami Cancer Institute | |
| Miami, Florida, United States, 33143 | |
| Advanced Research Institute | |
| New Port Richey, Florida, United States, 34652 | |
| Florida Foundation for Healthcare Research | |
| Ocala, Florida, United States, 34474 | |
| Urology Associates of Northeast Florida, PA | |
| Orange Park, Florida, United States, 32073 | |
| Winter Park Urology Associates | |
| Orlando, Florida, United States, 32803 | |
| Pinellas Urology, Inc. | |
| St. Petersburg, Florida, United States, 33710 | |
| Southeastern Urological Center | |
| Tallahassee, Florida, United States, 32308 | |
| United States, Georgia | |
| Georgia Urology Research Institute | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Indiana | |
| Ball Memorial Hospital | |
| Muncie, Indiana, United States, 47303 | |
| United States, Iowa | |
| Urological Associates PC | |
| Davenport, Iowa, United States, 52807 | |
| United States, Maryland | |
| Drs. Werner, Murdock and Francis PA Urology Associates | |
| Greenbelt, Maryland, United States, 20770 | |
| United States, Massachusetts | |
| Urology Associates of Middlesex County, Inc. | |
| Marlborough, Massachusetts, United States, 01752 | |
| United States, Michigan | |
| Lakeside Urology, P.C. | |
| Saint Joseph, Michigan, United States, 49085 | |
| Millennium Medical Center | |
| Southfield, Michigan, United States, 48075 | |
| United States, Missouri | |
| Kansas City Urology Care | |
| Kansas City, Missouri, United States, 64131 | |
| The Prostate Center of Greater St. Louis | |
| St. Louis, Missouri, United States, 63136 | |
| United States, Nevada | |
| American Academy of Urology | |
| Las Vegas, Nevada, United States, 89119 | |
| United States, New Jersey | |
| Urological Surgical Associates | |
| Edison, New Jersey, United States | |
| UroResearch, LLC | |
| Morristown, New Jersey, United States, 07960 | |
| Shaukat M. Qureshi, MD | |
| Pennsville, New Jersey, United States, 08070 | |
| Urology Associates | |
| Stratford, New Jersey, United States | |
| Associates in Urology, LLC | |
| West Orange, New Jersey, United States, 07052 | |
| United States, New York | |
| AccuMed Research Associates | |
| Garden City, New York, United States, 11530 | |
| Urological Surgeons of Long Island PC | |
| Garden City, New York, United States, 11530 | |
| Kingston Urological Assoc. | |
| Kingston, New York, United States, 12401 | |
| United States, North Carolina | |
| Cary Urology, P.A. | |
| Cary, North Carolina, United States, 27511 | |
| Matrix Research, LLC | |
| Greenville, North Carolina, United States, 29607 | |
| United States, Ohio | |
| The Urology Group | |
| Cincinnati, Ohio, United States, 45212 | |
| Southwest Urology | |
| Parma, Ohio, United States, 44129 | |
| United States, Pennsylvania | |
| Roger N. Andrews, MD Inc. | |
| Arcadia, Pennsylvania, United States, 91007 | |
| Urologic Surgery, PC | |
| Bala Cynwyd, Pennsylvania, United States, 19004 | |
| James W. Thompson, MD Ltd. | |
| Bryn Mawr, Pennsylvania, United States, 09010 | |
| Urology Institute of Pittsburgh | |
| Monroeville, Pennsylvania, United States, 15146 | |
| Albert Einstein Medical Center | |
| Philadelphia, Pennsylvania, United States, 19141 | |
| Center for Urologic Care of Berks County | |
| West Reading, Pennsylvania, United States, 19611 | |
| United States, South Carolina | |
| Grand Strand Urology | |
| Myrtle Beach, South Carolina, United States, 29572 | |
| United States, Tennessee | |
| Urology Center of the South P.C. | |
| Germantown, Tennessee, United States, 38138 | |
| Murfreesboro Medical Clinic | |
| Murfreesboro, Tennessee, United States, 37130 | |
| Urology Associates, PA | |
| Nashville, Tennessee, United States, 37209 | |
| United States, Texas | |
| Research Across America | |
| Carrollton, Texas, United States, 75010 | |
| United States, West Virginia | |
| CAMC Clinical Trials | |
| Charleston, West Virginia, United States, 25304 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Scott L. Pescatore, PharmD. | Novartis |
More Information
No publications provided
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00035997 History of Changes |
| Other Study ID Numbers: | CZOL446EUS24, US24 |
| Study First Received: | May 7, 2002 |
| Last Updated: | November 20, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Hormone-sensitive Prostate Cancer Prostate Cancer Bone Metastasis |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Prostatic Neoplasms Bone Neoplasms Bone Marrow Diseases Neoplastic Processes Neoplasms Pathologic Processes Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male |
Prostatic Diseases Bone Diseases Musculoskeletal Diseases Hematologic Diseases Hormones Zoledronic acid Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 16, 2013