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A Randomized, Phase III Study of Standard Dosing Versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer

Phase 3
18 Years
Open (Enrolling)
Breast Cancer, Metastatic Cancer, Multiple Myeloma and Plasma Cell Neoplasm, Musculoskeletal Complications, Pain, Prostate Cancer, Urinary Complications

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Trial Information

A Randomized, Phase III Study of Standard Dosing Versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer



- To compare the proportion of patients with metastatic breast cancer, metastatic
prostate cancer, or multiple myeloma involving bone who experience ≥ 1 skeletal-related
event during 2 years of treatment with zoledronic acid administered every 12 weeks vs
every 4 weeks.


- To compare pain scores of these patients, as assessed by the Brief Pain Inventory

- To compare the functional status (ECOG performance status) of these patients.

- To compare the incidence of osteonecrosis of the jaw in these patients.

- To compare the incidence of renal dysfunction in these patients.

- To compare the skeletal morbidity rate of these patients, defined as the number of
skeletal-related events per year.

OUTLINE: This is a multicenter study. Patients are stratified according to tumor type
(breast cancer vs prostate cancer vs multiple myeloma), baseline serum creatinine (≤ 1.4
mg/dL vs > 1.4 mg/dL), prior skeletal-related events (no vs yes), and prior oral
bisphosphate use (no vs yes). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive zoledronic acid IV over ≥ 15 minutes. Courses repeat 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 ≥ 15 minutes. Courses repeat every 12
weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Patients complete the Brief Pain Inventory questionnaire at baseline and then every 4 weeks
for 2 years.

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

Inclusion Criteria


- Histologically confirmed diagnosis of one of the following:

- Breast adenocarcinoma

- Prostate adenocarcinoma

- Multiple myeloma

- Has ≥ 1 site of bone metastasis or bone involvement by radiologic imaging, including
radiography, computed tomography (CT), PET scan, PET/CT scan, magnetic resonance
imaging, bone scan, or skeletal survey

- Indeterminate lesions should be confirmed by a second imaging method

- No known brain metastases

- Patients who develop brain metastases during the study are allowed to continue
study treatment as assigned


- ECOG performance status 0-2

- Creatinine clearance ≥ 30 mL/min

- Corrected serum calcium ≥ 8.0 mg/dL and < 11.6 mg/dL

- Not pregnant or nursing

- Negative pregnancy test


- Prior non-investigational chemotherapy, biologic therapy, and endocrine therapy in
the adjuvant or metastatic setting allowed

- No prior treatment with IV bisphosphonates

- Prior oral bisphosphonates allowed

- No concurrent oral bisphosphonates

- No prior treatment with radiopharmaceuticals

- Prior radioactive iodine allowed

- Prior brachytherapy allowed for patients with prostate cancer

- No prior denosumab

- Prior radiotherapy 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 radiotherapy to non-irradiated sites of bone

- No concurrent investigational agent(s)

- No concurrent treatment with other agents expected to alter osteoclast activity
(e.g., calcitonin, mithramycin, gallium nitrate, or any other bisphosphonate)

- Concurrent non-investigational antineoplastic therapies, including antiandrogens,
other hormonal agents, cytotoxic chemotherapy agents, and biologic response modifiers

- No concurrent investigational agents

- Concurrent standard radiotherapy to non-bony sites allowed

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients with ≥ 1 skeletal-related event within 2 years after randomization

Safety Issue:


Principal Investigator

Andrew L. Himelstein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Helen F. Graham Cancer Center at Christiana Hospital


United States: Federal Government

Study ID:




Start Date:

March 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • Metastatic Cancer
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Musculoskeletal Complications
  • Pain
  • Prostate Cancer
  • Urinary Complications
  • pain
  • musculoskeletal complications
  • urinary complications
  • adenocarcinoma of the prostate
  • stage IV breast cancer
  • recurrent breast cancer
  • male breast cancer
  • stage IV prostate cancer
  • recurrent prostate cancer
  • stage III multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • refractory multiple myeloma
  • bone metastases
  • Breast Neoplasms
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Prostatic Neoplasms



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St. Charles Mercy Hospital Oregon, Ohio  43616
North Coast Cancer Care, Incorporated Sandusky, Ohio  44870
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Good Samaritan Cancer Center Puyallup, Washington  98371
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Missouri Baptist Cancer Center St. Louis, Missouri  63131
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Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital Fort Lauderdale, Florida  33308
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler Savannah, Georgia  31405
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Michiana Hematology-Oncology, PC - Elkhart Elkhart, Indiana  46514
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Covenant Cancer Treatment Center Waterloo, Iowa  50702
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Cancer Center of Kansas, PA - Liberal Liberal, Kansas  67905
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Menorah Medical Center Overland Park, Kansas  66209
Saint Luke's Hospital - South Overland Park, Kansas  66213
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Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cotton-O'Neil Cancer Center Topeka, Kansas  66606
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Ochsner Health Center - Bluebonnet Baton Rouge, Louisiana  70809
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
Mercy Memorial Hospital - Monroe Monroe, Michigan  48162
Michiana Hematology Oncology PC - Niles Niles, Michigan  49120
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Lakeside Cancer Specialists, PLLC Saint Joseph, Michigan  49085
Willmar Cancer Center at Rice Memorial Hospital Willmar, Minnesota  56201
Heartland Hematology Oncology Associates, Incorporated Kansas City, Missouri  64118
North Kansas City Hospital Kansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City, Missouri  64111
Research Medical Center Kansas City, Missouri  64132
Saint Luke's East - Lee's Summit Lee's Summit, Missouri  64086
Heartland Regional Medical Center Saint Joseph, Missouri  64506
Saint Joseph Oncology, Incorporated Saint Joseph, Missouri  64507
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Northern Montana Hospital Havre, Montana  59501
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha, Nebraska  68124
Monter Cancer Center of the North Shore-LIJ Health System Lake Success, New York  11042
Leo W. Jenkins Cancer Center at ECU Medical School Greenville, North Carolina  27834
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210-1240
Grant Medical Center Cancer Care Columbus, Ohio  43215
Hematology Oncology Center Elyria, Ohio  44035
Community Cancer Center Elyria, Ohio  44035
Wayne Hospital Greenville, Ohio  45331
Knox Community Hospital Mount Vernon, Ohio  43050
Fisher-Titus Medical Center Norwalk, Ohio  44857
Flower Hospital Cancer Center Sylvania, Ohio  43560
St. Anne Mercy Hospital Toledo, Ohio  43623
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Salem Hospital Regional Cancer Care Services Salem, Oregon  97309-5014
Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania  18017
Geisinger Hazleton Cancer Center Hazleton, Pennsylvania  18201
Hematology and Oncology Associates of Northeastern Pennsylvania Scranton, Pennsylvania  18510
Fredericksburg Oncology, Incorporated Fredericksburg, Virginia  22401
Providence Centralia Hospital Centralia, Washington  98531-9027
Franciscan Cancer Center at St. Joseph Medical Center Tacoma, Washington  98405-3004
Marshfield Clinic - Chippewa Center Chippewa Falls, Wisconsin  54729
Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire, Wisconsin  54701
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center Green Bay, Wisconsin  54311
Vince Lombardi Cancer Clinic - Marinette Marinette, Wisconsin  54143
Marshfield Clinic - Lakeland Center Minocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's Hospital Rhinelander, Wisconsin  54501
Vince Lombardi Cancer Clinic - Sheboygan Sheboygan, Wisconsin  53081
Marshfield Clinic at Saint Michael's Hospital Stevens Point, Wisconsin  54481
Aurora Medical Center Summit, Wisconsin  53066
Vince Lombardi Cancer Clinic - Two Rivers Two Rivers, Wisconsin  54241
Oncology Alliance, SC - Milwaukee - West Wauwatosa, Wisconsin  53226
Marshfield Clinic - Weston Center Weston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin  54494
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center Pinehurst, North Carolina  28374
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
John H. Stroger, Jr. Hospital of Cook County Chicago, Illinois  60612-9985
Lincoln Medical and Mental Health Center Bronx, New York  10451
Genesys Regional Medical Center Grand Blanc, Michigan  48439-8066
Phoebe Cancer Center at Phoebe Putney Memorial Hospital Albany, Georgia  31702
Good Samaritan Cancer Center at Good Samaritan Hospital Kearney, Nebraska  68848-1990
Pardee Memorial Hospital Hendersonville, North Carolina  28791
Rutherford Hospital Rutherfordton, North Carolina  28139
Three Rivers Community Hospital Grants Pass, Oregon  97527
Dubs Cancer Center at Rogue Valley Medical Center Medford, Oregon  97504
Easton Regional Cancer Center at Easton Hospital Easton, Pennsylvania  18042
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Martha Jefferson Hospital Cancer Care Center Charlottesville, Virginia  22901
Regional Cancer Center at Oconomowoc Memorial Hospital Oconomowoc, Wisconsin  53066
Harold Alfond Center for Cancer Care Augusta, Maine  04330
Union Hospital of Cecil County Elkton MD, Maryland  21921
Kinston Medical Specialists Kinston, North Carolina  28501
Miriam Hospital Providence, Rhode Island  02906
Manchester Memorial Hospital Manchester, Connecticut  06040-4188
Jordan Hospital Club Cancer Center Plymouth, Massachusetts  02360
Phelps County Regional Medical Center Rolla, Missouri  65401
McLeod Regional Medical Center Florence, South Carolina  29501
Nalitt Cancer Institute at Staten Island University Hospital Staten Island, New York  10305
La Grange Memorial Hospital La Grange, Illinois  60525
Lakes Region General Hospital Laconia, New Hampshire  03246
Roper St. Francis Cancer Center at Roper Hospital Charleston, South Carolina  29401
University of Wisconcin Cancer Center at Aspirus Wausau Hospital Wausau, Wisconsin  54401
Veterans Affairs Medical Center - Iowa City Iowa City, Iowa  52246-2208
Cancer Center at Phoenixville Hospital Phoenixville, Pennsylvania  19460
Doctors Medical Center - San Pablo Campus San Pablo, California  94806
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Union Memorial Hospital Baltimore, Maryland  21218
Good Samaritan Hospital of Maryland Baltimore, Maryland  21239
Parvin Radiation Oncology Kansas City, Missouri  64116
East Bay Radiation Oncology Center Castro Valley, California  94546
Contra Costa Regional Medical Center Martinez, California  94553-3156
Memorial Medical Center Modesto, California  95355
El Camino Hospital Cancer Center Mountain View, California  94040
Larry G Strieff MD Medical Corporation Oakland, California  94609
Tom K Lee, Incorporated Oakland, California  94609
Bay Area Breast Surgeons, Incorporated Oakland, California  94609
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline, Illinois  61265
Iowa Blood and Cancer Care Cedar Rapids, Iowa  52402
Caritas St. Elizabeth's Medical Center Brighton, Massachusetts  02135-2997
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Concord, New Hampshire  03301
Center for Cancer Care at Exeter Hospital Exeter, New Hampshire  03833
New Hampshire Oncology - Hematology, PA - Hooksett Hooksett, New Hampshire  03106
Trinity CancerCare Center Minot, North Dakota  58701
United States Air Force Medical Center - Wright-Patterson Wright-Patterson AFB, Ohio  45433-5529
Riddle Memorial Hospital Cancer Center Media, Pennsylvania  19063
Cancer Center of Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
CCOP - Main Line Health Wynnewood, Pennsylvania  19096
AnMed Cancer Center Anderson, South Carolina  29621
Franciscan Skemp Healthcare - La Crosse Campus La Crosse, Wisconsin  54601
Fountain Valley, California  92708
Dale and Frances Hughes Cancer Center at Pocono Medical Center East Stroudsburg, Pennsylvania  18301
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
Cleveland Clinic Florida - Weston Weston, Florida  33331
Suniti Medical Corporation Merrillville, Indiana  46410
St. Mary's Regional Cancer Center at St. Mary's Medical Center Huntington, West Virginia  25702
Providence Cancer Center at PMCC Medford, Oregon  97504
Saint Mary's Regional Medical Center Reno, Nevada  89503
Lovelace Medical Center - Downtown Albuquerque, New Mexico  87102
Callahan Cancer Center at Great Plains Regional Medical Center North Platte, Nebraska  69103
Hematology Oncology Associates, PC Albuquerque, New Mexico  87106
Jersey Shore Cancer Center at Jersey Shore University Medical Center Neptune, New Jersey  07754-0397
Valley Medical Oncology Consultants - Castro Valley Castro Valley, California  94546
Valley Medical Oncology Fremont, California  94538
Memorial Hospital Cancer Center - Colorado Springs Colorado Springs, Colorado  80909
Ochsner Health Center - Covington Covington, Louisiana  70433
Addison Gilbert Hospital Gloucester, Massachusetts  01930
Immanuel St. Joseph's Mankato, Minnesota  56002
Skaggs Cancer Center at Skaggs Regional Medical Center Branson, Missouri  65616
Mercy Regional Cancer Center Janesville, Wisconsin  53547
Columbia Saint Mary's Hospital - Ozaukee Mequon, Wisconsin  53097
Columbia-Saint Mary's Cancer Care Center Milwaukee, Wisconsin  53211
Shore Regional Cancer Center at Memorial Hospital - Easton Easton, Maryland  21601
Minnesota Oncology - Maplewood Maplewood, Minnesota  55109
Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
Lakeview Hospital Stillwater, Minnesota  55082
Minnesota Oncology - Woodbury Woodbury, Minnesota  55125
Camino Medical Group - Treatment Center Mountain View, California  94040
Kings County Hospital Center Brooklyn, New York  11203
Cancer Institute at St. Joseph Medical Center Towson, Maryland  21204
Caritas Holy Family Hospital Methuen, Massachusetts  01844
Radiation Oncology Associates - Reno Reno, Nevada  89509
Clarian Arnett Cancer Care Lafayette, Indiana  47904
Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital Cooperstown, New York  13326
CCOP - Kansas City Prairie Village, Kansas  66208
Renown Institute for Cancer at Renown Regional Medical Center Reno, Nevada  89502
Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility Largo, Maryland  20774
Kaiser Permanente Medical Center - Fair Oaks Fairfax, Virginia  22033
Tufts Medical Center Cancer Center Boston, Massachusetts  02111
Langlade Memorial Hospital Antigo, Wisconsin  54409
Cancer Center of South Florida Foundation, Incorporated Lake Worth, Florida  33461
Foundation Medical Partners Nashua, New Hampshire  03060
Medical Oncology and Hematology Associates of North Virginia - Fairfax Fairfax, Virginia  22031
Southeast Cancer Center Cape Girardeau, Missouri  63703
Goldschmidt Cancer Center Jefferson City, Missouri  65109
Comprehensive Cancer Care, PC Saint Louis, Missouri  63141
Lakeside Hospital Omaha, Nebraska  68130
Clackamas Radiation Oncology Center Clackamas, Oregon  97015
Providence Newberg Medical Center Newberg, Oregon  97132
Willamette Falls Hospital Oregon City, Oregon  97045
Riverview UW Cancer Center at Riverview Hospital Wisconsin Rapids, Wisconsin  54494
Littleton Adventist Hospital Littleton, Colorado  80122
Parker Adventist Hospital Parker, Colorado  80138
Roger Maris Cancer Center at MeritCare Hospital Fargo, North Dakota  58122
St. Nicholas Hospital Sheboygan, Wisconsin  53081
Pacific Medical Center Seattle, Washington  98104
Commonwealth Hematology-Oncology, PC - Quincy Quincy, Massachusetts  02169
Overlake Cancer Center at Overlake Hospital Medical Center Bellevue, Washington  98004
Southern Ohio Medical Center Cancer Center Portsmouth, Ohio  45662
Feather River Hospital Cancer Center Paradise, California  95969
Seacoast Cancer Center at Wentworth - Douglass Hospital Dover, New Hampshire  03820
Trinitas Comprehensive Cancer Center at Trinitas Hospital Elizabeth, New Jersey  07207
Doylestown Hospital Cancer Center Doylestown, Pennsylvania  18901
Central Care Cancer Center at Carrie J. Babb Cancer Center Bolivar, Missouri  65613
Providence Regional Cancer Partnership Everett, Washington  98201
Kaiser Permanente at Capitol Hill Medical Center Washington, District of Columbia  20002
Kaiser Permanente at Woodlawn Medical Center Baltimore, Maryland  21244
Kaiser Permanente - Gaithersburg Medical Center Gaithersburg, Maryland  20879
Dickstein Cancer Treatment Center at White Plains Hospital Center White Plains, New York  10601
Carolina Blood and Cancer Care Associates, PA Lancaster, South Carolina  29720
Carolina Blood and Cancer Care Rock Hill, South Carolina  29732
Lexington Medical Center West Columbia, South Carolina  29169
St. Joseph Regional Medical Center Lewiston, Idaho  83501
D.N. Greenwald Center Mukwonago, Wisconsin  53149
Memorial Hospital at Gulfport Gulfport, Mississippi  39502