Pain Clinical Trial
Official title:
A Randomized, Phase III Study of Standard Dosing Versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer
Verified date | October 2018 |
Source | Alliance for Clinical Trials in Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
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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 |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States, Puerto Rico,
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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