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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00869206
Other study ID # CALGB-70604
Secondary ID CDR0000637947NCI
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2009
Est. completion date January 2017

Study information

Verified date October 2018
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase III trial studies two different schedules of zoledronic acid to compare how well they work in reducing bone-related complications in patients with breast cancer, prostate cancer, or multiple myeloma that has spread to other places in the body and have bone involvement. Bone-related complications are a major cause of morbidity in patients with metastatic prostate cancer, breast cancer, and multiple myeloma. Zoledronic acid may stop the growth of cancer cells in the bone and may help relieve some of the symptoms caused by bone metastases. It is not yet known whether giving zoledronic acid more or less frequently is more effective in treating patients with metastatic cancer that has spread to the bone.


Description:

PRIMARY OBJECTIVES:

I. To determine whether every-12-week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma involving bone, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization.

SECONDARY OBJECTIVES:

I. To compare pain scores (Brief Pain Inventory) of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing.

II. To compare the functional status (Eastern Cooperative Oncology Group [ECOG] performance status) of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing.

III. To compare the incidence of osteonecrosis of the jaw in patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing.

IV. To compare the incidence of renal dysfunction in patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing.

V. To compare the skeletal morbidity rate of these patients, defined as the number of skeletal-related events per year, of patients receiving every 12 week dosing to those receiving every 4 week dosing.

VI. To compare the suppression of serum markers of bone resorption of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing.

VII. To determine whether every 12 week therapy with zoledronic acid is not inferior to every-4-week therapy for each subgroup of patients with either breast cancer, prostate cancer, or multiple myeloma, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive zoledronic acid intravenously (IV) over at least 15 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive zoledronic acid IV over at least 15 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 4 weeks for 2 years from registration.


Recruitment information / eligibility

Status Completed
Enrollment 1822
Est. completion date January 2017
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Eligibility Criteria:

- Histologic documentation of one of the following: breast adenocarcinoma, prostate adenocarcinoma or multiple myeloma

- At least one site of bone metastasis or bone involvement by radiologic imaging including plain radiograph, computed tomography (CT), positron emission tomography (PET) scan, PET/CT scan, magnetic resonance imaging, bone scan, or skeletal survey; indeterminate lesions should be confirmed by a second imaging method

- No prior treatment with IV bisphosphonates is allowed; prior treatment with oral bisphosphonates is allowed, but they must be discontinued prior to the initiation of protocol therapy

- No prior treatment with denosumab

- No prior treatment with radiopharmaceuticals; prior treatment with radioactive iodine is allowed; prostate cancer patients treated with brachytherapy are eligible

- Prior radiation therapy to bone is allowed, provided that at least one site of bone metastasis has not been irradiated and radiation is completed prior to registration; there should be no plan for radiation therapy to non-irradiated sites of bone metastases

- Prior adjuvant and metastatic chemotherapy, biologic therapy, and endocrine therapy is allowed

- No current treatment with investigational agent(s)

- Patients with known brain metastases are not eligible; patients who develop brain metastases during the study will be allowed to continue treatment as assigned

- Not pregnant and not nursing

- ECOG performance status 0-2

- Calculated creatinine clearance >= 30 mL/min

- Corrected serum calcium >= 8.0 mg/dL (2.00 mmol/L) and < 11.6 mg/dL (2.90 mmol/L) * Corrected serum calcium should be calculated using standard institutional practices

Study Design


Intervention

Drug:
zoledronic acid
Given IV

Locations

Country Name City State
Puerto Rico San Juan City Hospital San Juan
United States Hickman Cancer Center at Bixby Medical Center Adrian Michigan
United States McDowell Cancer Center at Akron General Medical Center Akron Ohio
United States Phoebe Cancer Center at Phoebe Putney Memorial Hospital Albany Georgia
United States Hematology Oncology Associates, PC Albuquerque New Mexico
United States Lovelace Medical Center - Downtown Albuquerque New Mexico
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown Pennsylvania
United States McFarland Clinic, PC Ames Iowa
United States AnMed Cancer Center Anderson South Carolina
United States CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan
United States Saint Joseph Mercy Cancer Center Ann Arbor Michigan
United States Langlade Memorial Hospital Antigo Wisconsin
United States Winship Cancer Institute of Emory University Atlanta Georgia
United States Sturdy Memorial Hospital Attleboro Massachusetts
United States Harold Alfond Center for Cancer Care Augusta Maine
United States Aurora Presbyterian Hospital Aurora Colorado
United States Good Samaritan Hospital of Maryland Baltimore Maryland
United States Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center Baltimore Maryland
United States Kaiser Permanente at Woodlawn Medical Center Baltimore Maryland
United States Union Memorial Hospital Baltimore Maryland
United States CancerCare of Maine at Eastern Maine Medical Center Bangor Maine
United States Mary Bird Perkins Cancer Center - Baton Rouge Baton Rouge Louisiana
United States Ochsner Health Center - Bluebonnet Baton Rouge Louisiana
United States St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove Indiana
United States Overlake Cancer Center at Overlake Hospital Medical Center Bellevue Washington
United States MeritCare Bemidji Bemidji Minnesota
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States Billings Clinic - Downtown Billings Montana
United States CCOP - Montana Cancer Consortium Billings Montana
United States Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana
United States St. Vincent Healthcare Cancer Care Services Billings Montana
United States Bismarck Cancer Center Bismarck North Dakota
United States Medcenter One Hospital Cancer Care Center Bismarck North Dakota
United States Mid Dakota Clinic, PC Bismarck North Dakota
United States St. Alexius Medical Center Cancer Center Bismarck North Dakota
United States Mountain States Tumor Institute at St. Luke's Regional Medical Center Boise Idaho
United States Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Boise Idaho
United States Central Care Cancer Center at Carrie J. Babb Cancer Center Bolivar Missouri
United States Tufts Medical Center Cancer Center Boston Massachusetts
United States Boulder Community Hospital Boulder Colorado
United States Wood County Oncology Center Bowling Green Ohio
United States Bozeman Deaconess Cancer Center Bozeman Montana
United States St. Joseph's Medical Center Brainerd Minnesota
United States Skaggs Cancer Center at Skaggs Regional Medical Center Branson Missouri
United States Caritas St. Elizabeth's Medical Center Brighton Massachusetts
United States Lincoln Medical and Mental Health Center Bronx New York
United States Kings County Hospital Center Brooklyn New York
United States SUNY Downstate Medical Center Brooklyn New York
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Roswell Park Cancer Institute Buffalo New York
United States Fairview Ridges Hospital Burnsville Minnesota
United States St. James Healthcare Cancer Care Butte Montana
United States Aultman Cancer Center at Aultman Hospital Canton Ohio
United States Southeast Cancer Center Cape Girardeau Missouri
United States East Bay Radiation Oncology Center Castro Valley California
United States Valley Medical Oncology Consultants - Castro Valley Castro Valley California
United States Cedar Rapids Oncology Associates Cedar Rapids Iowa
United States Iowa Blood and Cancer Care Cedar Rapids Iowa
United States Mercy Regional Cancer Center at Mercy Medical Center Cedar Rapids Iowa
United States St. Luke's Hospital Cedar Rapids Iowa
United States Providence Centralia Hospital Centralia Washington
United States Cancer Center of Kansas, PA - Chanute Chanute Kansas
United States Roper St. Francis Cancer Center at Roper Hospital Charleston South Carolina
United States Martha Jefferson Hospital Cancer Care Center Charlottesville Virginia
United States Saint Luke's Hospital Chesterfield Missouri
United States John H. Stroger, Jr. Hospital of Cook County Chicago Illinois
United States Louis A. Weiss Memorial Hospital Chicago Illinois
United States University of Illinois Cancer Center Chicago Illinois
United States Veterans Affairs Medical Center - Chicago Westside Hospital Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Marshfield Clinic - Chippewa Center Chippewa Falls Wisconsin
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States MetroHealth Cancer Care Center at MetroHealth Medical Center Cleveland Ohio
United States Medical Oncology and Hematology Associates - West Des Moines Clive Iowa
United States Memorial Hospital Cancer Center - Colorado Springs Colorado Springs Colorado
United States Penrose Cancer Center at Penrose Hospital Colorado Springs Colorado
United States Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri
United States Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus Ohio
United States CCOP - Columbus Columbus Ohio
United States Doctors Hospital at Ohio Health Columbus Ohio
United States Grant Medical Center Cancer Care Columbus Ohio
United States Mount Carmel Health - West Hospital Columbus Ohio
United States Riverside Methodist Hospital Cancer Care Columbus Ohio
United States New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Concord New Hampshire
United States Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota
United States Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital Cooperstown New York
United States Ochsner Health Center - Covington Covington Louisiana
United States Geisinger Cancer Institute at Geisinger Health Danville Pennsylvania
United States Genesis Regional Cancer Center at Genesis Medical Center Davenport Iowa
United States CCOP - Dayton Dayton Ohio
United States David L. Rike Cancer Center at Miami Valley Hospital Dayton Ohio
United States Good Samaritan Hospital Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Samaritan North Cancer Care Center Dayton Ohio
United States Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn Michigan
United States Decatur Memorial Hospital Cancer Care Institute Decatur Illinois
United States Veterans Affairs Medical Center - Atlanta (Decatur) Decatur Georgia
United States Grady Memorial Hospital Delaware Ohio
United States CCOP - Colorado Cancer Research Program Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - St. Luke's Medical Center Denver Colorado
United States Rose Medical Center Denver Colorado
United States St. Anthony Central Hospital Denver Colorado
United States St. Joseph Hospital Denver Colorado
United States CCOP - Iowa Oncology Research Association Des Moines Iowa
United States John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa
United States John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa
United States Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa
United States Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa
United States Cancer Center of Kansas, PA - Dodge City Dodge City Kansas
United States Seacoast Cancer Center at Wentworth - Douglass Hospital Dover New Hampshire
United States Doylestown Hospital Cancer Center Doylestown Pennsylvania
United States Delaware County Regional Cancer Center at Delaware County Memorial Hospital Drexel Hill Pennsylvania
United States CCOP - Duluth Duluth Minnesota
United States Duluth Clinic Cancer Center - Duluth Duluth Minnesota
United States Miller - Dwan Medical Center Duluth Minnesota
United States Dale and Frances Hughes Cancer Center at Pocono Medical Center East Stroudsburg Pennsylvania
United States CCOP - Hematology-Oncology Associates of Central New York East Syracuse New York
United States Easton Regional Cancer Center at Easton Hospital Easton Pennsylvania
United States Shore Regional Cancer Center at Memorial Hospital - Easton Easton Maryland
United States Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire Wisconsin
United States Midelfort Clinic - Luther Eau Claire Wisconsin
United States Fairview Southdale Hospital Edina Minnesota
United States Cancer Center of Kansas, PA - El Dorado El Dorado Kansas
United States Trinitas Comprehensive Cancer Center at Trinitas Hospital Elizabeth New Jersey
United States Elkhart Clinic, LLC Elkhart Indiana
United States Elkhart General Hospital Elkhart Indiana
United States Michiana Hematology-Oncology, PC - Elkhart Elkhart Indiana
United States Union Hospital of Cecil County Elkton Maryland
United States Elmhurst Hospital Center Elmhurst New York
United States Community Cancer Center Elyria Ohio
United States Hematology Oncology Center Elyria Ohio
United States Swedish Medical Center Englewood Colorado
United States Green Bay Oncology, Limited - Escanaba Escanaba Michigan
United States Evanston Hospital Evanston Illinois
United States Providence Regional Cancer Partnership Everett Washington
United States Center for Cancer Care at Exeter Hospital Exeter New Hampshire
United States Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital Fairbanks Alaska
United States Kaiser Permanente Medical Center - Fair Oaks Fairfax Virginia
United States Medical Oncology and Hematology Associates of North Virginia - Fairfax Fairfax Virginia
United States North Bay Cancer Center Fairfield California
United States CCOP - MeritCare Hospital Fargo North Dakota
United States MeritCare Broadway Fargo North Dakota
United States Roger Maris Cancer Center at MeritCare Hospital Fargo North Dakota
United States St. Francis Hospital Federal Way Washington
United States Blanchard Valley Medical Associates Findlay Ohio
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States McLeod Regional Medical Center Florence South Carolina
United States Front Range Cancer Specialists Fort Collins Colorado
United States Poudre Valley Hospital Fort Collins Colorado
United States Broward General Medical Center Cancer Center Fort Lauderdale Florida
United States Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Fort Lauderdale Florida
United States Cancer Center of Kansas - Fort Scott Fort Scott Kansas
United States Middletown Regional Hospital Franklin Ohio
United States Fredericksburg Oncology, Incorporated Fredericksburg Virginia
United States Leonard C. Ferguson Cancer Center Freeport Illinois
United States Valley Medical Oncology Fremont California
United States Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota
United States Kaiser Permanente - Gaithersburg Medical Center Gaithersburg Maryland
United States Charles R. Wood Cancer Center at Glens Falls Hospital Glens Falls New York
United States Addison Gilbert Hospital Gloucester Massachusetts
United States Wayne Memorial Hospital, Incorporated Goldsboro North Carolina
United States Genesys Regional Medical Center Grand Blanc Michigan
United States Altru Cancer Center at Altru Hospital Grand Forks North Dakota
United States Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center Grand Island Nebraska
United States St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Grand Junction Colorado
United States Three Rivers Community Hospital Grants Pass Oregon
United States Great Falls Clinic - Main Facility Great Falls Montana
United States Sletten Cancer Institute at Benefis Healthcare Great Falls Montana
United States North Colorado Medical Center Greeley Colorado
United States Green Bay Oncology, Limited at St. Mary's Hospital Green Bay Wisconsin
United States Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin
United States St. Mary's Hospital Medical Center - Green Bay Green Bay Wisconsin
United States St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin
United States Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center Green Bay Wisconsin
United States Leo W. Jenkins Cancer Center at ECU Medical School Greenville North Carolina
United States Wayne Hospital Greenville Ohio
United States Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan
United States Memorial Hospital at Gulfport Gulfport Mississippi
United States Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford Connecticut
United States Northern Montana Hospital Havre Montana
United States Geisinger Hazleton Cancer Center Hazleton Pennsylvania
United States St. Peter's Hospital Helena Montana
United States Pardee Memorial Hospital Hendersonville North Carolina
United States Veterans Affairs Medical Center - Hines Hines Illinois
United States New Hampshire Oncology - Hematology, PA - Hooksett Hooksett New Hampshire
United States St. Mary's Regional Cancer Center at St. Mary's Medical Center Huntington West Virginia
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Cancer Center of Kansas-Independence Independence Kansas
United States Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa
United States Veterans Affairs Medical Center - Iowa City Iowa City Iowa
United States Dickinson County Healthcare System Iron Mountain Michigan
United States Foote Memorial Hospital Jackson Michigan
United States Veterans Affairs Medical Center - Jackson Jackson Mississippi
United States Mayo Clinic - Jacksonville Jacksonville Florida
United States Queens Cancer Center of Queens Hospital Jamaica New York
United States Mercy Regional Cancer Center Janesville Wisconsin
United States Goldschmidt Cancer Center Jefferson City Missouri
United States Joliet Oncology-Hematology Associates, Limited - West Joliet Illinois
United States Ella Milbank Foshay Cancer Center at Jupiter Medical Center Jupiter Florida
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Glacier Oncology, PLLC Kalispell Montana
United States Kalispell Medical Oncology at KRMC Kalispell Montana
United States Kalispell Regional Medical Center Kalispell Montana
United States Heartland Hematology Oncology Associates, Incorporated Kansas City Missouri
United States North Kansas City Hospital Kansas City Missouri
United States Parvin Radiation Oncology Kansas City Missouri
United States Research Medical Center Kansas City Missouri
United States Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City Missouri
United States Good Samaritan Cancer Center at Good Samaritan Hospital Kearney Nebraska
United States Keesler Air Force Base Medical Center Keesler Air Force Base Mississippi
United States Charles F. Kettering Memorial Hospital Kettering Ohio
United States Cancer Center of Kansas, PA - Kingman Kingman Kansas
United States Kinston Medical Specialists Kinston North Carolina
United States Cascade Cancer Center at Evergreen Hospital Medical Center Kirkland Washington
United States Thompson Cancer Survival Center Knoxville Tennessee
United States Howard Community Hospital Kokomo Indiana
United States Franciscan Skemp Healthcare - La Crosse Campus La Crosse Wisconsin
United States Gundersen Lutheran Center for Cancer and Blood La Crosse Wisconsin
United States La Grange Memorial Hospital La Grange Illinois
United States Rebecca and John Moores UCSD Cancer Center La Jolla California
United States Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte Indiana
United States Lakes Region General Hospital Laconia New Hampshire
United States Clarian Arnett Cancer Care Lafayette Indiana
United States Monter Cancer Center of the North Shore-LIJ Health System Lake Success New York
United States Cancer Center of South Florida Foundation, Incorporated Lake Worth Florida
United States Carolina Blood and Cancer Care Associates, PA Lancaster South Carolina
United States Fairfield Medical Center Lancaster Ohio
United States Lancaster General Hospital Lancaster Pennsylvania
United States St. Mary Regional Cancer Center Langhorne Pennsylvania
United States Sparrow Regional Cancer Center Lansing Michigan
United States Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility Largo Maryland
United States CCOP - Nevada Cancer Research Foundation Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
United States Tunnell Cancer Center at Beebe Medical Center Lewes Delaware
United States St. Joseph Regional Medical Center Lewiston Idaho
United States Cancer Center of Kansas, PA - Liberal Liberal Kansas
United States Lima Memorial Hospital Lima Ohio
United States St. Rita's Medical Center Lima Ohio
United States Cancer Resource Center - Lincoln Lincoln Nebraska
United States Littleton Adventist Hospital Littleton Colorado
United States St. Mary Mercy Hospital Livonia Michigan
United States Sky Ridge Medical Center Lone Tree Colorado
United States Hope Cancer Care Center at Longmont United Hospital Longmont Colorado
United States McKee Medical Center Loveland Colorado
United States Manchester Memorial Hospital Manchester Connecticut
United States CCOP - North Shore University Hospital Manhasset New York
United States Don Monti Comprehensive Cancer Center at North Shore University Hospital Manhasset New York
United States Holy Family Memorial Medical Center Cancer Care Center Manitowoc Wisconsin
United States Immanuel St. Joseph's Mankato Minnesota
United States HealthEast Cancer Care at St. John's Hospital Maplewood Minnesota
United States Minnesota Oncology - Maplewood Maplewood Minnesota
United States Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio
United States Bay Area Cancer Care Center at Bay Area Medical Center Marinette Wisconsin
United States Vince Lombardi Cancer Clinic - Marinette Marinette Wisconsin
United States Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton New Jersey
United States Upper Michigan Cancer Center at Marquette General Hospital Marquette Michigan
United States Marshfield Clinic - Marshfield Center Marshfield Wisconsin
United States Contra Costa Regional Medical Center Martinez California
United States Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City Iowa
United States Northwest Ohio Oncology Center Maumee Ohio
United States Dubs Cancer Center at Rogue Valley Medical Center Medford Oregon
United States Providence Cancer Center at PMCC Medford Oregon
United States Riddle Memorial Hospital Cancer Center Media Pennsylvania
United States Columbia Saint Mary's Hospital - Ozaukee Mequon Wisconsin
United States Suniti Medical Corporation Merrillville Indiana
United States Caritas Holy Family Hospital Methuen Massachusetts
United States CCOP - Mount Sinai Medical Center Miami Beach Florida
United States Saint Anthony Memorial Health Centers Michigan City Indiana
United States Middlesex Hospital Cancer Center Middletown Connecticut
United States Columbia-Saint Mary's Cancer Care Center Milwaukee Wisconsin
United States Providence Milwaukie Hospital Milwaukie Oregon
United States Hennepin County Medical Center - Minneapolis Minneapolis Minnesota
United States Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis Minnesota
United States Marshfield Clinic - Lakeland Center Minocqua Wisconsin
United States Trinity CancerCare Center Minot North Dakota
United States Michiana Hematology-Oncology, PC - South Bend Mishawaka Indiana
United States Saint Joseph Regional Medical Center Mishawaka Indiana
United States Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana
United States Montana Cancer Specialists at Montana Cancer Center Missoula Montana
United States Memorial Medical Center Modesto California
United States Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline Illinois
United States Community Cancer Center of Monroe Monroe Michigan
United States Mercy Memorial Hospital - Monroe Monroe Michigan
United States Knox Community Hospital Mount Vernon Ohio
United States Camino Medical Group - Treatment Center Mountain View California
United States El Camino Hospital Cancer Center Mountain View California
United States D.N. Greenwald Center Mukwonago Wisconsin
United States Hematology Oncology Consultants - Naperville Naperville Illinois
United States Foundation Medical Partners Nashua New Hampshire
United States Jersey Shore Cancer Center at Jersey Shore University Medical Center Neptune New Jersey
United States George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus New Britain Connecticut
United States Long Island Jewish Medical Center New Hyde Park New York
United States CCOP - Ochsner New Orleans Louisiana
United States MBCCOP - LSU Health Sciences Center New Orleans Louisiana
United States Medical Center of Louisiana - New Orleans New Orleans Louisiana
United States Ochsner Cancer Institute at Ochsner Clinic Foundation New Orleans Louisiana
United States New York Weill Cornell Cancer Center at Cornell University New York New York
United States NYU Cancer Institute at New York University Medical Center New York New York
United States CCOP - Christiana Care Health Services Newark Delaware
United States Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio
United States Providence Newberg Medical Center Newberg Oregon
United States Cancer Center of Kansas, PA - Newton Newton Kansas
United States Michiana Hematology Oncology PC - Niles Niles Michigan
United States Callahan Cancer Center at Great Plains Regional Medical Center North Platte Nebraska
United States Leavey Cancer Center at Northridge Hospital Medical Center Northridge California
United States Fisher-Titus Medical Center Norwalk Ohio
United States Alta Bates Summit Medical Center - Summit Campus Oakland California
United States Bay Area Breast Surgeons, Incorporated Oakland California
United States CCOP - Bay Area Tumor Institute Oakland California
United States Highland General Hospital Oakland California
United States Larry G Strieff MD Medical Corporation Oakland California
United States Tom K Lee, Incorporated Oakland California
United States Regional Cancer Center at Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Green Bay Oncology, Limited - Oconto Falls Oconto Falls Wisconsin
United States Providence St. Peter Hospital Regional Cancer Center Olympia Washington
United States Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha Nebraska
United States CCOP - Missouri Valley Cancer Consortium Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Immanuel Medical Center Omaha Nebraska
United States Lakeside Hospital Omaha Nebraska
United States UNMC Eppley Cancer Center at the University of Nebraska Medical Center Omaha Nebraska
United States St. Charles Mercy Hospital Oregon Ohio
United States Toledo Clinic - Oregon Oregon Ohio
United States Willamette Falls Hospital Oregon City Oregon
United States Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando Florida
United States McCreery Cancer Center at Ottumwa Regional Ottumwa Iowa
United States Menorah Medical Center Overland Park Kansas
United States Saint Luke's Hospital - South Overland Park Kansas
United States Palo Alto Medical Foundation Palo Alto California
United States Cancer Center of Paoli Memorial Hospital Paoli Pennsylvania
United States Feather River Hospital Cancer Center Paradise California
United States Parker Adventist Hospital Parker Colorado
United States Cancer Center of Kansas, PA - Parsons Parsons Kansas
United States Regional Cancer Center at Singing River Hospital Pascagoula Mississippi
United States Albert Einstein Cancer Center Philadelphia Pennsylvania
United States Joan Karnell Cancer Center at Pennsylvania Hospital Philadelphia Pennsylvania
United States Cancer Center at Phoenixville Hospital Phoenixville Pennsylvania
United States FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center Pinehurst North Carolina
United States Veterans Affairs Medical Center - Pittsburgh Pittsburgh Pennsylvania
United States Jordan Hospital Club Cancer Center Plymouth Massachusetts
United States Michiana Hematology Oncology PC - Plymouth Plymouth Indiana
United States St. Joseph Mercy Oakland Pontiac Michigan
United States Mercy Regional Cancer Center at Mercy Hospital Port Huron Michigan
United States CCOP - Columbia River Oncology Program Portland Oregon
United States Kaiser Permanente Health Care - Portland Portland Oregon
United States Providence Cancer Center at Providence Portland Medical Center Portland Oregon
United States Providence St. Vincent Medical Center Portland Oregon
United States Southern Ohio Medical Center Cancer Center Portsmouth Ohio
United States CCOP - Kansas City Prairie Village Kansas
United States Cancer Center of Kansas, PA - Pratt Pratt Kansas
United States Miriam Hospital Providence Rhode Island
United States Rhode Island Hospital Comprehensive Cancer Center Providence Rhode Island
United States Roger Williams Medical Center Providence Rhode Island
United States St. Mary - Corwin Regional Medical Center Pueblo Colorado
United States Good Samaritan Cancer Center Puyallup Washington
United States Commonwealth Hematology-Oncology, PC - Quincy Quincy Massachusetts
United States All Saints Cancer Center at Wheaton Franciscan Healthcare Racine Wisconsin
United States Radiation Oncology Associates - Reno Reno Nevada
United States Renown Institute for Cancer at Renown Regional Medical Center Reno Nevada
United States Saint Mary's Regional Medical Center Reno Nevada
United States Ministry Medical Group at Saint Mary's Hospital Rhinelander Wisconsin
United States Marshfield Clinic - Indianhead Center Rice Lake Wisconsin
United States Reid Hospital & Health Care Services Richmond Indiana
United States Veterans Affairs Medical Center - Richmond Richmond Virginia
United States Virginia Commonwealth University Massey Cancer Center Richmond Virginia
United States West Suburban Center for Cancer Care River Forest Illinois
United States Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale Minnesota
United States Mayo Clinic Cancer Center Rochester Minnesota
United States Carolina Blood and Cancer Care Rock Hill South Carolina
United States Phelps County Regional Medical Center Rolla Missouri
United States William Beaumont Hospital - Royal Oak Campus Royal Oak Michigan
United States Rutherford Hospital Rutherfordton North Carolina
United States Seton Cancer Institute at Saint Mary's - Saginaw Saginaw Michigan
United States CentraCare Clinic - River Campus Saint Cloud Minnesota
United States Coborn Cancer Center Saint Cloud Minnesota
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Lakeland Regional Cancer Care Center - St. Joseph Saint Joseph Michigan
United States Lakeside Cancer Specialists, PLLC Saint Joseph Michigan
United States Saint Joseph Oncology, Incorporated Saint Joseph Missouri
United States Comprehensive Cancer Care, PC Saint Louis Missouri
United States Missouri Baptist Cancer Center Saint Louis Missouri
United States Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Saint Louis Missouri
United States CCOP - Metro-Minnesota Saint Louis Park Minnesota
United States Park Nicollet Cancer Center Saint Louis Park Minnesota
United States Regions Hospital Cancer Care Center Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Salem Hospital Regional Cancer Care Services Salem Oregon
United States Cancer Center of Kansas, PA - Salina Salina Kansas
United States Naval Medical Center - San Diego San Diego California
United States Veterans Affairs Medical Center - San Diego San Diego California
United States Doctors Medical Center - San Pablo Campus San Pablo California
United States North Coast Cancer Care, Incorporated Sandusky Ohio
United States Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah Georgia
United States Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler Savannah Georgia
United States Mayo Clinic Scottsdale Scottsdale Arizona
United States Hematology and Oncology Associates of Northeastern Pennsylvania Scranton Pennsylvania
United States Mercy Hospital Cancer Center - Scranton Scranton Pennsylvania
United States CCOP - Virginia Mason Research Center Seattle Washington
United States Pacific Medical Center Seattle Washington
United States Virginia Mason Medical Center Seattle Washington
United States St. Francis Cancer Center at St. Francis Medical Center Shakopee Minnesota
United States St. Nicholas Hospital Sheboygan Wisconsin
United States Vince Lombardi Cancer Clinic - Sheboygan Sheboygan Wisconsin
United States Welch Cancer Center at Sheridan Memorial Hospital Sheridan Wyoming
United States Mercy Medical Center - Sioux City Sioux City Iowa
United States Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa
United States St. Luke's Regional Medical Center Sioux City Iowa
United States Avera Cancer Institute Sioux Falls South Dakota
United States Medical X-Ray Center, PC Sioux Falls South Dakota
United States Sanford Cancer Center at Sanford USD Medical Center Sioux Falls South Dakota
United States CCOP - Northern Indiana CR Consortium South Bend Indiana
United States Memorial Hospital of South Bend South Bend Indiana
United States CCOP - Upstate Carolina Spartanburg South Carolina
United States Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina
United States Baystate Regional Cancer Program at D'Amour Center for Cancer Care Springfield Massachusetts
United States CCOP - Cancer Research for the Ozarks Springfield Missouri
United States Community Hospital of Springfield and Clark County Springfield Ohio
United States Hulston Cancer Center at Cox Medical Center South Springfield Missouri
United States Regional Cancer Center at Memorial Medical Center Springfield Illinois
United States St. John's Regional Health Center Springfield Missouri
United States Geisinger Medical Group - Scenery Park State College Pennsylvania
United States Nalitt Cancer Institute at Staten Island University Hospital Staten Island New York
United States Iredell Memorial Hospital Statesville North Carolina
United States Marshfield Clinic at Saint Michael's Hospital Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay Wisconsin
United States Aurora Medical Center Summit Wisconsin
United States Flower Hospital Cancer Center Sylvania Ohio
United States Veterans Affairs Medical Center - Syracuse Syracuse New York
United States Allenmore Hospital Tacoma Washington
United States CCOP - Northwest Tacoma Washington
United States Franciscan Cancer Center at St. Joseph Medical Center Tacoma Washington
United States MultiCare Regional Cancer Center at Tacoma General Hospital Tacoma Washington
United States St. Clare Hospital Tacoma Washington
United States North Suburban Medical Center Thornton Colorado
United States Mercy Hospital of Tiffin Tiffin Ohio
United States CCOP - Toledo Community Hospital Toledo Ohio
United States Medical University of Ohio Cancer Center Toledo Ohio
United States St. Anne Mercy Hospital Toledo Ohio
United States St. Vincent Mercy Medical Center Toledo Ohio
United States Toledo Clinic, Incorporated - Main Clinic Toledo Ohio
United States Toledo Hospital Toledo Ohio
United States Cotton-O'Neil Cancer Center Topeka Kansas
United States Cancer Institute at St. Joseph Medical Center Towson Maryland
United States UVMC Cancer Care Center at Upper Valley Medical Center Troy Ohio
United States LaFortune Cancer Center at St. John Medical Center Tulsa Oklahoma
United States Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa Oklahoma
United States Vince Lombardi Cancer Clinic - Two Rivers Two Rivers Wisconsin
United States CCOP - Carle Cancer Center Urbana Illinois
United States Southwest Washington Medical Center Cancer Center Vancouver Washington
United States Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey
United States Fox Chase Virtua Health Cancer Program at Virtua West Jersey Voorhees New Jersey
United States Ridgeview Medical Center Waconia Minnesota
United States St. John Macomb Hospital Warren Michigan
United States Kaiser Permanente at Capitol Hill Medical Center Washington District of Columbia
United States Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington District of Columbia
United States Sibley Memorial Hospital Washington District of Columbia
United States Covenant Cancer Treatment Center Waterloo Iowa
United States Waukesha Memorial Hospital Regional Cancer Center Waukesha Wisconsin
United States University of Wisconcin Cancer Center at Aspirus Wausau Hospital Wausau Wisconsin
United States Fulton County Health Center Wauseon Ohio
United States Oncology Alliance, SC - Milwaukee - West Wauwatosa Wisconsin
United States Cancer Center of Kansas, PA - Wellington Wellington Kansas
United States Chester County Hospital West Chester Pennsylvania
United States Lexington Medical Center West Columbia South Carolina
United States Jennersville Regional Hospital West Grove Pennsylvania
United States Mount Carmel St. Ann's Cancer Center Westerville Ohio
United States Cleveland Clinic Florida - Weston Weston Florida
United States Marshfield Clinic - Weston Center Weston Wisconsin
United States Michiana Hematology Oncology PC - La Porte Westville Indiana
United States Exempla Lutheran Medical Center Wheat Ridge Colorado
United States Dickstein Cancer Treatment Center at White Plains Hospital Center White Plains New York
United States Associates in Womens Health, PA - North Review Wichita Kansas
United States Cancer Center of Kansas, PA - Medical Arts Tower Wichita Kansas
United States Cancer Center of Kansas, PA - Wichita Wichita Kansas
United States CCOP - Wichita Wichita Kansas
United States Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas
United States Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania
United States Willmar Cancer Center at Rice Memorial Hospital Willmar Minnesota
United States Zimmer Cancer Center at New Hanover Regional Medical Center Wilmington North Carolina
United States Cancer Center of Kansas, PA - Winfield Winfield Kansas
United States Forsyth Regional Cancer Center at Forsyth Medical Center Winston-Salem North Carolina
United States Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Riverview UW Cancer Center at Riverview Hospital Wisconsin Rapids Wisconsin
United States Minnesota Oncology - Woodbury Woodbury Minnesota
United States United States Air Force Medical Center - Wright-Patterson Wright-Patterson Air Force Base Ohio
United States CCOP - Main Line Health Wynnewood Pennsylvania
United States Lankenau Cancer Center at Lankenau Hospital Wynnewood Pennsylvania
United States Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia Ohio
United States North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington
United States Genesis - Good Samaritan Hospital Zanesville Ohio

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With at Least One Skeletal-related Event (SRE) Within 2 Years After Randomization To determine whether every-12-week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma involving bone, as measured by the proportion of patients who would have experienced at least one skeletal related event within 24 months after randomization. 2 years
Secondary Average Pain Intensity Score as Assessed by the Brief Pain Inventory (BPI) Questionnaire To compare pain scores (Brief Pain Inventory) of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The change scores were evaluated in a general linear model with repeated measures for treatment effect and the time trend with patient-specific characteristics being adjusted for the mean interference score. Specifically the difference in score change per 4 weeks for Arm I using Arm II as the reference is reported. The score of the BPI questionnaire ranges from 0 being no pain to 10 being the most pain. The average score is reported for each arm below. from baseline up to 2 years
Secondary Average ECOG Performance Status To compare functional status (ECOG performance status) of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The change scores were evaluated in a general linear model with repeated measures for treatment effect and the time trend with patient-specific characteristics being adjusted. Specifically the difference in score change per 4 weeks for Arm I using Arm II as the reference is reported. ECOG performance status is a measurement of a patients disability ranging from 0, fully active and able to carry out all pre disease performance without restriction, to 5, dead. The average performance status is reported below by arm. from baseline up to 2 years
Secondary Incidence of Osteonecrosis of the Jaw To compare the incidence of osteonecrosis of the jaw in patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The percentage of participants with osteonecrosis is reported here. from baseline up to 2 years
Secondary Incidence of Renal Dysfunction To compare the incidence of renal dysfunction of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The percentage of patients with renal dysfunction, defined as grade 3 or grade 4 increased creatinine (Common Terminology Criteria for Adverse Events version 3.0), will be reported here. from baseline up to 2 years
Secondary Skeletal Morbidity Rate To compare the skeletal morbidity rate, defined as the number of skeletal-related events per year, of patients receiving every 12 week dosing to those receiving every 4 week dosing. from baseline up to 2 years
Secondary Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Breast Cancer) To compare the suppression of serum markers of bone resorption of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The number of patients with high & low CTX values by arm will be reported here. from baseline up to 2 years
Secondary Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Breast Cancer To determine whether every 12 week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with breast cancer, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization. from baseline up to 24 months
Secondary Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Prostate Cancer To determine whether every 12 week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with prostate cancer, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization. from baseline up to 24 months
Secondary Proportion of Patients Having at Least One SRE Within 24 Months After Randomization for the Subgroups of Patients With Multiple Myeloma To determine whether every 12 week therapy with zoledronic acid is not inferior to every-4-week therapy for patients with multiple myeloma, as measured by the proportion who experience at least one skeletal related event within 24 months after randomization. from baseline up to 24 months
Secondary Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Prostate Cancer) To compare the suppression of serum markers of bone resorption of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The number of patients with high & low CTX values by arm will be reported here. from baseline up to 24 months
Secondary Bone Turnover Assessed by Serum C-telopeptide (CTX) Levels (Multiple Myeloma) To compare the suppression of serum markers of bone resorption of patients with metastatic breast cancer, metastatic prostate cancer, or myeloma involving bone receiving every 12 week dosing of zoledronic acid to those receiving every 4 week dosing. The number of patients with high & low CTX values by arm will be reported here. from baseline up to 24 months
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