Efficacy and Safety of Zoledronic Acid ( Every 4 Weeks vs. Every 12 Weeks) in Patients With Documented Bone Metastases From Bone Cancer
This study is currently recruiting participants.
Verified March 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00320710
First received: April 28, 2006
Last updated: March 22, 2013
Last verified: March 2013
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Purpose
Clinical trial in breast cancer patients with bone metastases pretreated with zoledronic acid. Looking at the effectiveness of giving zoledronic acid every 4 weeks versus every 12 weeks given over 1 year. This study is prospective, double-blind, stratified, multi-center, and two-arm.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Zometa® (zoledronic acid) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Prospective, Randomized, Double-blind, Stratified, Multi-center, 2-arm Trial of the Continued Efficacy and Safety of Zoledronic Acid (Every 4 Weeks vs. Every 12 Weeks) in Patients With Documented Bone Metastases From Breast Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Zoledronic acid
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Proportion of patients who experience at least one Skeletal Related Event (SRE) during the study period (SRE rate) [ Time Frame: during the study period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to first skeletal related event(SRE),defined as time(in days)from randomization to first occurrence of any SRE up to wk 52 in the study.SRE includes:pathologic bone fracture,radiation therapy/surgery to bone,spinal cord compression. [ Time Frame: during the study period ] [ Designated as safety issue: No ]
- Time to first individual type of SRE [ Time Frame: during the study period ] [ Designated as safety issue: No ]
- • Bone pain score, assessed by: • the brief pain inventory (BPI) at visits 2,3,4,5,8,11 and end of study (EOS) visits • numerical rating scale weekly through month 4 via the touch-tone telephone system (IVRS) [ Time Frame: during the study period ] [ Designated as safety issue: No ]
- • Urinary N-Tx/Cr ratio and serum bone specific alkaline phosphatase assessed at baseline and monthly through week 48. [ Time Frame: during the study period ] [ Designated as safety issue: No ]
- Safety comparisons between the two study groups [ Time Frame: during the study perion ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 423 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Zometa® q 4 weeks | Drug: Zometa® (zoledronic acid) |
| Experimental: Zometa® q12 weeks | Drug: Zometa® (zoledronic acid) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Female patients ≥ 18 years of age
- Confirmed breast cancer with bone metastasis.
- Pretreated with Zometa®, or Aredia (pamidronate) or all sequential regimens of both, for a minimum of 9 doses.
Exclusion Criteria:
- Abnormal kidney function determined by serum creatinine levels.
- Current active dental problems including: ongoing infection of the teeth or jawbone; current exposed bone in the mouth; and current or prior diagnosis of osteonecrosis of the jaw.
- Recent (within 8 weeks) or planned dental or jaw surgery (e.g., extraction, implants)
- Diagnosis of metabolic bone disease other than osteoporosis (e.g., Paget's disease of bone)
- Known hypersensitivity to Zometa
- Treatment with other investigational drugs within 30 days prior to randomization.
Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00320710
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Contacts
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | |
| Contact: Novartis Pharmaceuticals |
Hide Study LocationsLocations
| United States, Alabama | |
| Clinical Research Consultants, Inc. | Withdrawn |
| Hoover, Alabama, United States, 35216 | |
| Gulf Coast MBCCOP | Withdrawn |
| Mobile, Alabama, United States, 36607 | |
| United States, Alaska | |
| Providence Alaska Medical Center Cancer Research | Active, not recruiting |
| Anchorage, Alaska, United States, 99508 | |
| Alaska Cancer Research & Education Center | Withdrawn |
| Anchorage, Alaska, United States, 99508 | |
| United States, Arizona | |
| Palo Verde Hematology & Oncology | Withdrawn |
| Glendale, Arizona, United States, 85304 | |
| United States, Arkansas | |
| Heritage Physicians Group Oncology | Completed |
| Hot Springs, Arkansas, United States, 71913 | |
| The Center for Chest Care | Recruiting |
| Springdale, Arkansas, United States, 72764 | |
| Contact 479-751-2100 | |
| Principal Investigator: J. Thaddeus Beck | |
| United States, California | |
| Pacific Cancer Medical Center, Inc. | Active, not recruiting |
| Anaheim, California, United States, 92801 | |
| Shapiro & Stafford & Yee & Polanski | Withdrawn |
| Arcadia, California, United States, 91007 | |
| South Bay Oncology Hematology Partners | Active, not recruiting |
| Campbell, California, United States, 95008 | |
| Bay Area Cancer Research | Terminated |
| Concord, California, United States, 94520 | |
| Pacific Coast Hem/Onc | Completed |
| Fountain Valley, California, United States, 92708 | |
| Compassionate Cancer Care Medical Group 900 South Main Street | Withdrawn |
| Fountain Valley, California, United States, 92708 | |
| California Oncology of the Central Valley | Withdrawn |
| Fresno, California, United States, 93710 | |
| Cancer Care Associates | Withdrawn |
| Fresno, California, United States, 93720 | |
| California Cancer Care Marian Speciality | Withdrawn |
| Greenbrae, California, United States, 94904 | |
| Wilshire Oncology Medical Group | Recruiting |
| La Verne, California, United States, 91750 | |
| Contact 909-596-5333 | |
| Principal Investigator: Linda D. Bosserman | |
| Kenmar Research Institute | Completed |
| Los Angeles, California, United States, 90057 | |
| Clinical Trials and Research Associates | Withdrawn |
| Montebello, California, United States, 90604 | |
| North Valley Hematology/Oncology Providence Holy Cross Medical | Completed |
| Northridge, California, United States, 91328 | |
| Medical Oncology Care Associates | Completed |
| Orange, California, United States, 92868 | |
| Ventura County Hematology and Oncology | Recruiting |
| Oxnard, California, United States, 93030 | |
| Contact 805-485-8709 | |
| Principal Investigator: Rosemary McIntyre | |
| Comprehensive Cancer Center | Withdrawn |
| Palm Springs, California, United States, 92262 | |
| The Office of Dr. Swarna Chanduri, MD | Recruiting |
| Pomona, California, United States, 91767 | |
| Principal Investigator: Swarna Chanduri | |
| High Plains Oncology | Withdrawn |
| Pueblo, California, United States, 81004 | |
| Access Clinical Research | Withdrawn |
| Rancho Mirage, California, United States, 92270 | |
| Cancer and Blood of the Desert | Completed |
| Rancho Mirage, California, United States, 92270 | |
| University of California Davis Cancer Center | Completed |
| Sacramento, California, United States, 95817 | |
| Kaiser Permanente San Diego | Withdrawn |
| San Diego, California, United States, 92108 | |
| Sant Chawla Inc | Withdrawn |
| Santa Monica, California, United States, 90403 | |
| University of California at Los Angeles | Recruiting |
| Sylmar, California, United States, 91342 | |
| Contact 818-364-4287 | |
| Principal Investigator: Jeffrey Miller | |
| United States, Colorado | |
| University of Colorado | Withdrawn |
| Aurora, Colorado, United States, 80045 | |
| Denver Health Medical Center CACZ885M2301 | Withdrawn |
| Denver, Colorado, United States, 80204-4507 | |
| United States, Connecticut | |
| Eastern Connecticut Hematology & Oncology Associates | Active, not recruiting |
| Norwich, Connecticut, United States, 06360 | |
| United States, District of Columbia | |
| Washington Hospital Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact 202-877-3061 | |
| Principal Investigator: Karen Smith | |
| Georgetown University/Lombardi Cancer Center | Completed |
| Washington, District of Columbia, United States, 20007-2197 | |
| United States, Florida | |
| Pasco Hernando Oncology Associates, PA | Withdrawn |
| Brooksville, Florida, United States, 34613 | |
| Cancer Research Network | Withdrawn |
| Hollywood, Florida, United States, 33021 | |
| Baptist Cancer Center | Completed |
| Jacksonville, Florida, United States, 32209 | |
| Jupiter Medical Center-Clinical Research Office | Withdrawn |
| Jupiter, Florida, United States, 33458 | |
| Lake Heart and Cancer Medical Center | Withdrawn |
| Leesburg, Florida, United States, 34748 | |
| Osler Medical Clinical Research | Withdrawn |
| Melbourne, Florida, United States, 32901 | |
| Pasco Hernando Oncology | Recruiting |
| New Port Richey, Florida, United States, 34652 | |
| Contact 813-842-2795 | |
| Principal Investigator: Kapisthalam Kumar | |
| Pasco Hernando Oncology | Completed |
| New Port Richey, Florida, United States, 34652 | |
| Cancer Research Network, Inc (CRN) | Withdrawn |
| Plantation, Florida, United States, 33324 | |
| Hematology Oncology Assoc of Central Brevard | Withdrawn |
| Rockledge, Florida, United States, 32955 | |
| The Office of Dr. Elizabeth Tan-Chiu, MD PA | Withdrawn |
| Tamarac, Florida, United States, 33321 | |
| H. Lee Moffitt Cancer Center/University of South Florida Hematology/Oncology | Withdrawn |
| Tampa, Florida, United States, 33613 | |
| United States, Georgia | |
| Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2) | Withdrawn |
| Atlanta, Georgia, United States, 30322 | |
| Eisenhower Army Medical Center Room 8B40 | Withdrawn |
| Fort Gordon, Georgia, United States, 30905 | |
| Suburban Hematology-Oncology | Recruiting |
| Lawrenceville, Georgia, United States, 30045 | |
| Principal Investigator: Alexander Saker | |
| United States, Illinois | |
| NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr | Withdrawn |
| Chicago, Illinois, United States, 60611 | |
| Evanston Northwestern Healthcare Medical Group | Active, not recruiting |
| Evanston, Illinois, United States, 60201 | |
| Edward Cancer Center | Active, not recruiting |
| Naperville, Illinois, United States, 60540 | |
| Mid Illinois Hematology Oncology | Withdrawn |
| Normal, Illinois, United States, 61761 | |
| Midwest Cancer Research Group | Completed |
| Skokie, Illinois, United States, 60077 | |
| United States, Indiana | |
| Investigative Clinical Research | Active, not recruiting |
| Indianapolis, Indiana, United States, 46254 | |
| Cancer Care Center | Completed |
| New Albany, Indiana, United States, 47150 | |
| Associated Physicians & Surgeons Clinic | Active, not recruiting |
| Terre Haute, Indiana, United States, 47804 | |
| United States, Iowa | |
| Medical Associates Clinic, PC | Recruiting |
| Dubuque, Iowa, United States, 52001 | |
| Contact 563-584-3650 | |
| Principal Investigator: Christine Holm | |
| University of Iowa Health Care | Active, not recruiting |
| Iowa City, Iowa, United States, 52242-1091 | |
| Siouxland Hematology-Oncology Associates LLP | Recruiting |
| Sioux City, Iowa, United States, 51101 | |
| Contact 712-252-9326 | |
| Principal Investigator: Steve Kahanic | |
| Cedar Valley Medical Specialsts | Withdrawn |
| Waterloo, Iowa, United States, 50701 | |
| United States, Kansas | |
| Kansas City Cancer Center KCCC Business Office | Withdrawn |
| Overland Park, Kansas, United States, 66210 | |
| Mowery Clinic LLC Tammy Walker Cancer Center | Withdrawn |
| Salina, Kansas, United States, 67401 | |
| Cotton O'Neil Oncology Clinic | Completed |
| Topeka, Kansas, United States, 66606 | |
| Cancer Center of Kansas | Recruiting |
| Witchita, Kansas, United States, 67214-3728 | |
| Contact 316-262-4467 | |
| Principal Investigator: Shaker R. Dakhil | |
| United States, Kentucky | |
| Kentucky Lung Clinic & Kentucky Sleep Clinic | Recruiting |
| Hazard, Kentucky, United States, 41701 | |
| Principal Investigator: Hassan Ghazal | |
| Lexington Oncology Associates | Withdrawn |
| Lexington, Kentucky, United States, 40503 | |
| United States, Louisiana | |
| Cabrini Center for Cancer Care | Recruiting |
| Alexandria, Louisiana, United States, 71301 | |
| Contact 318-448-6917 | |
| Principal Investigator: Steven Saccaro | |
| Medical Oncology LLC | Withdrawn |
| Baton Rouge, Louisiana, United States, 70809 | |
| Southwest Oncology Associates Ltd. | Completed |
| Lafayette, Louisiana, United States, 70503 | |
| LSU Health Sciences Center | Terminated |
| Shreveport, Louisiana, United States, 71130 | |
| United States, Maryland | |
| Greenbaum Cancer Center | Recruiting |
| Baltimore, Maryland, United States, 21201-1595 | |
| Contact 410-328-2565 | |
| Principal Investigator: Katherine Tkaczuk | |
| The Harry and Jeanette Weinberg Cancer Institute at Franklin | Terminated |
| Baltimore, Maryland, United States, 21237 | |
| St. Agnes Hospital | Completed |
| Baltimore, Maryland, United States, 21229 | |
| Center for Cancer & Blood Disorders | Recruiting |
| Bethesda, Maryland, United States, 20817 | |
| Contact 301-571-2016 | |
| Principal Investigator: Ralph Boccia | |
| Frederick Memorial Hospital | Completed |
| Frederick, Maryland, United States, 21701 | |
| Chesapeake Oncology Hematology Associates P.A. | Withdrawn |
| Glen Burnie, Maryland, United States, 21061 | |
| Calvert Memorial Hospital | Withdrawn |
| Prince Frederick, Maryland, United States, 20678 | |
| Kaiser Permanente - Maryland | Withdrawn |
| Rockville, Maryland, United States, 20850 | |
| United States, Massachusetts | |
| Caritas Holy Family Hospital | Completed |
| Methuen, Massachusetts, United States, 01844 | |
| United States, Michigan | |
| University of Michigan Clinical Trials Office | Active, not recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Osteopathic Medical Oncology and Hematology | Withdrawn |
| Clinton Township, Michigan, United States, 48037 | |
| Henry Ford Hospital Oncology | Active, not recruiting |
| Detroit, Michigan, United States, 48202 | |
| Wayne State University | Completed |
| Detroit, Michigan, United States, 48201 | |
| Great Lakes Cancer Management Specialists | Withdrawn |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| Hematology Oncology Associates of Ohio & Michigan PC | Withdrawn |
| Lambertville, Michigan, United States, 48144 | |
| St. Joseph Mercy Oakland | Completed |
| Pontiac, Michigan, United States, 48341 | |
| Oncology Care Associates, PLLC | Active, not recruiting |
| St. Joseph, Michigan, United States, 49085 | |
| United States, Minnesota | |
| SMDC Health System | Withdrawn |
| Duluth, Minnesota, United States, 55805 | |
| St. Luke's Hospital and Health Network | Completed |
| Duluth, Minnesota, United States, 55805 | |
| Univ. of Minnesota Cancer Center 420 Delaware St. | Terminated |
| Minneapolis, Minnesota, United States, 55455 | |
| Fairview Clinical Trial Services | Active, not recruiting |
| Minneapolis, Minnesota, United States, 55414 | |
| Hubert H. Humphrey Cancer Center | Completed |
| Robbinsdale, Minnesota, United States, 55422 | |
| United States, Mississippi | |
| Hattiesburg Clinic, P.A. | Withdrawn |
| Hattiesburg, Mississippi, United States, 39401 | |
| Jackson Oncology Associates | Terminated |
| Jackson, Mississippi, United States, 39202 | |
| United States, Missouri | |
| Capitol Comprehensive Cancer Care Clinic | Completed |
| Jefferson City, Missouri, United States, 65109 | |
| St.Joseph Oncology INC | Withdrawn |
| Saint Joseph, Missouri, United States, 64507 | |
| The Center for Cancer Care and Research | Completed |
| St. Louis, Missouri, United States, 63141 | |
| United States, Nebraska | |
| Nebraska Hematology-Oncology PC | Withdrawn |
| Lincoln, Nebraska, United States, 68506 | |
| United States, Nevada | |
| Nevada Cancer Centers 2851 North Tenaya Way | Completed |
| Las Vegas, Nevada, United States, 89109 | |
| United States, New Hampshire | |
| Kingsbury Center for Cancer Care | Withdrawn |
| Keene, New Hampshire, United States, 03431 | |
| United States, New Jersey | |
| Essex Oncology of North Jersey PA | Withdrawn |
| Belleville, New Jersey, United States, 07109 | |
| Center for Cancer and Hematologic Disease | Completed |
| Cherry Hill, New Jersey, United States, 08003 | |
| Saint Barnabas Medical Center | Recruiting |
| Livingston, New Jersey, United States, 07039 | |
| Contact 973-322-2470 | |
| Principal Investigator: Richard A Michaelson | |
| UMDNJ ADMC 6 Room 625 | Withdrawn |
| Newark, New Jersey, United States, 07101 | |
| Somerset Hematology Oncology Associates | Completed |
| Somerset, New Jersey, United States, 08873 | |
| The Office of Dr. Parvez Dara, MD | Withdrawn |
| Toms River, New Jersey, United States, 08755 | |
| Cooper Cancer Center | Withdrawn |
| Voorhees, New Jersey, United States, 08043 | |
| United States, New Mexico | |
| New Mexico Oncology Hematology | Withdrawn |
| Albuquerque, New Mexico, United States, 87109 | |
| United States, New York | |
| Advanced Oncology Associates | Completed |
| Armonk, New York, United States, 10504 | |
| SUNY Downstate Medical Center | Completed |
| Brooklyn, New York, United States, 11203 | |
| Guthrie Cancer Center | Withdrawn |
| Corning, New York, United States, 14830 | |
| Queens Medical Associates, PC | Withdrawn |
| Fresh Meadows, New York, United States, 11365 | |
| Arena Oncology Associates, PC | Recruiting |
| Great Neck, New York, United States, 11021 | |
| Principal Investigator: Anna Kurzyna-Solinas | |
| Benedictine Hospital | Completed |
| Kingston, New York, United States, 12401 | |
| Memorial Sloan Kettering Cancer Center | Withdrawn |
| New York, New York, United States, 10065 | |
| Beth Israel Medical Center | Withdrawn |
| New York, New York, United States, 10003 | |
| Columbia Presbyterian Medical Center | Withdrawn |
| New York, New York, United States, 10032 | |
| Jmaes P. Wilmot Cancer Center | Withdrawn |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Alamance Regional Medical Cancer Center | Completed |
| Burlington, North Carolina, United States, 27215 | |
| Northeast Oncology Associates Suite 250 | Withdrawn |
| Concord, North Carolina, United States, 28025 | |
| United States, Ohio | |
| Barberton Citizens Hospital | Completed |
| Barberton, Ohio, United States, 44203 | |
| Gabrail Cancer Center | Active, not recruiting |
| Canton, Ohio, United States, 44718 | |
| Physicians Associates, Inc. (Oncology Partner's Network) Oncology Partner's Network | Withdrawn |
| Cincinnati, Ohio, United States, 45238 | |
| Ohio Cancer Specialists | Completed |
| Mansfield, Ohio, United States, 44907 | |
| Meridia Cancer Center | Withdrawn |
| Mayfield Heights, Ohio, United States, 44124 | |
| Hematology/Oncology Consultants Inc. | Recruiting |
| West Worthington, Ohio, United States, 43235 | |
| Contact 614-846-0044 | |
| Principal Investigator: Leslie Laufman | |
| Trilogy Cancer Care | Withdrawn |
| Wooster, Ohio, United States, 44691 | |
| Forum Health | Withdrawn |
| Youngstown, Ohio, United States, 44501 | |
| United States, Oklahoma | |
| Cancer Care Associates | Withdrawn |
| Okalahoma City, Oklahoma, United States, 73112 | |
| Cancer Care Associates | Withdrawn |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Oregon | |
| Bay Area Hospital - Pharmacy | Withdrawn |
| Coos Bay, Oregon, United States, 97420 | |
| The Corvallis Clinic, P.C. | Terminated |
| Corvallis, Oregon, United States, 97330 | |
| United States, Pennsylvania | |
| Patterson Cancer Care Center | Withdrawn |
| Coudersport, Pennsylvania, United States, 16915 | |
| Milton S Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
| Contact 717-531-8677 | |
| Principal Investigator: Alan Lipton | |
| Conemaugh Cancer Care Center | Withdrawn |
| Johnstown, Pennsylvania, United States, 15905 | |
| Lancaster Cancer Center | Active, not recruiting |
| Lancaster, Pennsylvania, United States, 17601 | |
| Rittenhouse Hemotology/Oncology | Withdrawn |
| Philadelphia, Pennsylvania, United States, 19146 | |
| U of Pittsburgh Cancer Institute Magee-Womens Hospital | Terminated |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Guthrie Cancer Center | Recruiting |
| Sayre, Pennsylvania, United States, 18840 | |
| Principal Investigator: Edward O'Brien | |
| Mainline Oncology Hematology Assoc. | Completed |
| Wynnewood, Pennsylvania, United States, 19096 | |
| United States, South Carolina | |
| Medical Associates, PA | Withdrawn |
| Charleston, South Carolina, United States, 29403 | |
| M. Francisco Gonzalez, MD., FACP | Completed |
| Columbia, South Carolina, United States, 29203 | |
| Santee Hematology/Oncology | Recruiting |
| Sumter, South Carolina, United States, 29150 | |
| Contact 803-934-8833 | |
| Principal Investigator: Bill W. Clowney | |
| Lexington Oncology Associates | Withdrawn |
| West Columbia, South Carolina, United States, 29169 | |
| United States, South Dakota | |
| Sioux Valley Clinic Clinical Research Center | Withdrawn |
| Sioux Falls, South Dakota, United States, 57104 | |
| United States, Tennessee | |
| The Jones Clinic | Withdrawn |
| Germantown, Tennessee, United States, 38138 | |
| United States, Texas | |
| Coastal Bend Cancer Center | Withdrawn |
| Corpus Christi, Texas, United States, 78463 | |
| MD Anderson Cancer Center/University of Texas 1155 Herman Pressler Street | Active, not recruiting |
| Houston, Texas, United States, 77031 | |
| Cancer Centers of South Texas | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact 210-595-5300 | |
| Principal Investigator: Yuhoe Gia Dice | |
| United States, Vermont | |
| Rutland Regional Medical Center | Withdrawn |
| Rutland, Vermont, United States, 05701 | |
| United States, Virginia | |
| Community Practice | Withdrawn |
| Woodbridge, Virginia, United States, 22191 | |
| United States, Washington | |
| Providence Everett Medical Clinic | Completed |
| Everett, Washington, United States, 98201 | |
| Seattle Cancer Care Alliance Seattle Cancer Care Alliance | Withdrawn |
| Seattle, Washington, United States, 98109 | |
| Swedish Cancer Institute | Withdrawn |
| Seattle, Washington, United States, 98104 | |
| Rockwood Clinic Rockwood Clinic, PS | Recruiting |
| Spokane, Washington, United States, 99202 | |
| Contact 509-838-2531 | |
| Principal Investigator: Kirk A Lund | |
| United States, West Virginia | |
| Greenbriar Oncology Clinic | Withdrawn |
| Lewisburg, West Virginia, United States, 24901 | |
| Morgantown Internal Medicine | Withdrawn |
| Morgantown, West Virginia, United States, 26505 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | Active, not recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Puerto Rico | |
| San Juan VA Hospital Research Department A53 | Withdrawn |
| San Juan, Puerto Rico, 00921 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00320710 History of Changes |
| Other Study ID Numbers: | CZOL446E2352 |
| Study First Received: | April 28, 2006 |
| Last Updated: | March 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Breast cancer zoledronic acid bone metastases |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasm Metastasis Bone Neoplasms Bone Marrow Diseases Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplastic Processes |
Pathologic Processes Bone Diseases Musculoskeletal Diseases Hematologic Diseases Zoledronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013