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Continued Efficacy and Safety of Zoledronic Acid (q 4 Wks vs. q 12 Wks) in the 2nd Year of Treatment in Patients With Bone Metastases From Breast Cancer

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Zoledronic acid
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, zoledronic acid, bone metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Female patients ≥ 18 years of age. Confirmed breast cancer with bone metastasis. Pretreated with Zometa®, or Aredia (pamidronate) or all sequential regimens of both, for a minimum of 9 doses; Exclusion Criteria: Abnormal kidney function determined by serum creatinine levels. Current active dental problems including: ongoing infection of the teeth or jawbone; current exposed bone in the mouth; and current or prior diagnosis of osteonecrosis of the jaw. Recent (within 8 weeks) or planned dental or jaw surgery (e.g., extraction, implants). Diagnosis of metabolic bone disease other than osteoporosis (e.g., Paget's disease of bone). Known hypersensitivity to Zometa. Treatment with other investigational drugs within 30 days prior to randomization. Other protocol-defined exclusion criteria may have applied.

Sites / Locations

  • Providence Alaska Medical Center Cancer Research
  • Heritage Physicians Group Oncology
  • The Center for Chest Care
  • Pacific Cancer Medical Center, Inc.
  • South Bay Oncology Hematology Partners
  • Bay Area Cancer Research
  • Pacific Coast Hem/Onc
  • Wilshire Oncology Medical Group
  • Kenmar Research Institute
  • North Valley Hematology/Oncology Providence Holy Cross Medical
  • Medical Oncology Care Associates
  • Ventura County Hematology and Oncology
  • The Office of Dr. Swarna Chanduri, MD
  • Access Clinical Research
  • Cancer and Blood of the Desert
  • University of California Davis Cancer Center
  • University of California at Los Angeles
  • Denver Health Medical Center CACZ885M2301
  • Eastern Connecticut Hematology & Oncology Associates
  • Georgetown University/Lombardi Cancer Center
  • Washington Hospital Center
  • Baptist Cancer Center
  • Pasco Hernando Oncology
  • The Office of Dr. Elizabeth Tan-Chiu, MD PA
  • Suburban Hematology-Oncology
  • NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr
  • Evanston Northwestern Healthcare Medical Group
  • Edward Cancer Center
  • Midwest Cancer Research Group
  • Investigative Clinical Research
  • Cancer Care Center
  • Associated Physicians & Surgeons Clinic
  • Medical Associates Clinic, PC
  • University of Iowa Health Care
  • Siouxland Hematology-Oncology Associates LLP
  • Cotton O'Neil Oncology Clinic
  • Cancer Center of Kansas
  • Kentucky Lung Clinic & Kentucky Sleep Clinic
  • Lexington Oncology Associates
  • Cabrini Center for Cancer Care
  • Southwest Oncology Associates Ltd.
  • Greenbaum Cancer Center
  • St. Agnes Hospital
  • The Harry and Jeanette Weinberg Cancer Institute at Franklin
  • Center for Cancer & Blood Disorders
  • Frederick Memorial Hospital
  • Caritas Holy Family Hospital
  • University of Michigan Clinical Trials Office
  • Wayne State University
  • Henry Ford Hospital Oncology
  • Oncology Care Associates, PLLC
  • St. Luke's Hospital and Health Network
  • Fairview Clinical Trial Services
  • Univ. of Minnesota Cancer Center 420 Delaware St.
  • Hubert H. Humphrey Cancer Center
  • Jackson Oncology Associates
  • Capitol Comprehensive Cancer Care Clinic
  • The Center for Cancer Care and Research
  • Nebraska Hematology-Oncology PC
  • Nevada Cancer Centers 2851 North Tenaya Way
  • Center for Cancer and Hematologic Disease
  • Saint Barnabas Medical Center
  • Somerset Hematology Oncology Associates
  • Advanced Oncology Associates
  • Arena Oncology Associates, PC
  • Benedictine Hospital
  • Beth Israel Medical Center
  • Columbia Presbyterian Medical Center
  • Memorial Sloan Kettering Cancer Center
  • Jmaes P. Wilmot Cancer Center
  • Alamance Regional Medical Cancer Center
  • Northeast Oncology Associates Suite 250
  • Barberton Citizens Hospital
  • Gabrail Cancer Center
  • Ohio Cancer Specialists
  • Hematology/Oncology Consultants Inc.
  • Trilogy Cancer Care
  • Bay Area Hospital - Pharmacy
  • The Corvallis Clinic, P.C.
  • Milton S Hershey Medical Center
  • Lancaster Cancer Center
  • U of Pittsburgh Cancer Institute Magee-Womens Hospital
  • Guthrie Cancer Center
  • Mainline Oncology Hematology Assoc.
  • M. Francisco Gonzalez, MD., FACP
  • Santee Hematology/Oncology
  • MD Anderson Cancer Center/University of Texas 1155 Herman Pressler Street
  • Cancer Centers of South Texas
  • Providence Everett Medical Clinic
  • Seattle Cancer Care Alliance Seattle Cancer Care Alliance
  • Rockwood Clinic Rockwood Clinic, PS
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Zoledronic acid every (q) 4 weeks

Zoledronic acid q 12 weeks

Placebo / zoledronic acid

Arm Description

Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.

Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.

Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were swithced to the zoledronic acid q 4 weeks according to a study amendment.

Outcomes

Primary Outcome Measures

Proportion of Patients Who Experienced at Least One Skeletal Related Event (SRE)
An SRE was defined as a pathologic fracture (vertebral and non-vertebral), spinal cord compression, radiation to bone or surgery to bone.

Secondary Outcome Measures

Time to First SRE
An SRE was defined as a pathologic bone fracture (vertebral and non-vertebral), spinal cord compression, radiation to bone, or surgery to bone. The time to first individual SRE was defined as the date of randomization to the date of first occurrence of any SRE.
Time to First Individual Type of SRE
Types of SREs analyzed were pathologic fractures (vertebral and non-vertebral), spinal cord compression, radiation to bone and surgery to bone. The time to first indvidual SRE was defined as the date of randomization to the date of the first occurrence of any individual SRE.
Change From Baseline in Mean Composite Brief Pain Inventory (BPI) Score
Participants completed a BPI short form which is a 9 item self-administered questionnaire used to evaluate the severity of a participant's pain and the impact of this pain on the participant's daily functioning. The participant rates his or her worst, least, average, and current pain intensity, lists current treatments and perceived effectiveness, and rates the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. The BPI composite score, which was calculated as the average of items 3, 4, 5 and 6 (worst pain, least pain, average pain and pain right now), ranged from 0 (best possible outcome, no pain) to 10 (worst possible outcome, pain as bad as you can imagine). A positive change from baseline indicates worsening.
Change From Baseline in Mean Analgesic Score
The analgesic score indicates the types of pain medication used. The scores range as follows: 0 = none medication; 1 = minor analgesics (aspirin, NSAID, acetaminophen, propoxyphene, etc.); 2 = Tranquilizers, antidepressants, muscle relaxants, and steroids; 3 = Mild narcotics (oxycodone, meperidine, codeine, etc.); and 4 = Strong narcotics (morphine, hydromorphone, etc.). A positive change from baseline indicates worsening.
Change From Baseline in Urinary N-telopeptide / Creatinine Ratio
Urine samples were collected to obtain n-telopeptide and creatinine values.
Change From Baseline in Serum Bone Specific Alkaline Phosphatase
Serum samples were collected to obtain bone specific alkaline phosphatase values.
Skeletal Morbidity Rate
An SMR for a patient was defined as the "number of occurrences" of any (or a particular) SRE allowing for only 1 event in any 3-week interval, divided by the "time at risk" in years. The "number of occurrences" and the "time at risk" were counts of SRE and the time from the randomization date. Counting began from randomization in the way that every counted event was followed by a 20-day period during which no SRE was counted, nor was the time counted as "at risk". For example, if a patient had 1 SRE during the study, the "time at risk" was calculated as the total number of days in the study minus the 20-day follow-up period for that SRE. If a patient had no SRE events, the entire study period was counted as "time at risk". This SMR calculation method had the advantage of avoiding multiple counts of possibly interdependent SREs (e.g. having 1 fracture increases the probability of having a subsequent SRE).

Full Information

First Posted
April 28, 2006
Last Updated
August 18, 2014
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00320710
Brief Title
Continued Efficacy and Safety of Zoledronic Acid (q 4 Wks vs. q 12 Wks) in the 2nd Year of Treatment in Patients With Bone Metastases From Breast Cancer
Official Title
A Prospective, Randomized, Double-blind, Stratified, Multi-center, 2-arm Trial of the Continued Efficacy and Safety of Zoledronic Acid (Every 4 Weeks vs. Every 12 Weeks) in in the 2nd Year of Treatment in Patients With Documented Bone Metastases From Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Clinical trial in breast cancer patients with bone metastases pretreated for approximately 1 year with a standard zoledronic acid regimen. Looking at the continued effectiveness and safety of giving zoledronic acid every 4 weeks versus every 12 weeks given over 1 year. This study is prospective, double-blind, stratified, multi-center, and two-arm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, zoledronic acid, bone metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
416 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zoledronic acid every (q) 4 weeks
Arm Type
Experimental
Arm Description
Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
Arm Title
Zoledronic acid q 12 weeks
Arm Type
Experimental
Arm Description
Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
Arm Title
Placebo / zoledronic acid
Arm Type
Experimental
Arm Description
Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were swithced to the zoledronic acid q 4 weeks according to a study amendment.
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Other Intervention Name(s)
Zoledronate, ZOL446, Zometa
Intervention Description
4mg IV
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to zoledronic acid
Primary Outcome Measure Information:
Title
Proportion of Patients Who Experienced at Least One Skeletal Related Event (SRE)
Description
An SRE was defined as a pathologic fracture (vertebral and non-vertebral), spinal cord compression, radiation to bone or surgery to bone.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Time to First SRE
Description
An SRE was defined as a pathologic bone fracture (vertebral and non-vertebral), spinal cord compression, radiation to bone, or surgery to bone. The time to first individual SRE was defined as the date of randomization to the date of first occurrence of any SRE.
Time Frame
52 weeks
Title
Time to First Individual Type of SRE
Description
Types of SREs analyzed were pathologic fractures (vertebral and non-vertebral), spinal cord compression, radiation to bone and surgery to bone. The time to first indvidual SRE was defined as the date of randomization to the date of the first occurrence of any individual SRE.
Time Frame
52 weeks
Title
Change From Baseline in Mean Composite Brief Pain Inventory (BPI) Score
Description
Participants completed a BPI short form which is a 9 item self-administered questionnaire used to evaluate the severity of a participant's pain and the impact of this pain on the participant's daily functioning. The participant rates his or her worst, least, average, and current pain intensity, lists current treatments and perceived effectiveness, and rates the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. The BPI composite score, which was calculated as the average of items 3, 4, 5 and 6 (worst pain, least pain, average pain and pain right now), ranged from 0 (best possible outcome, no pain) to 10 (worst possible outcome, pain as bad as you can imagine). A positive change from baseline indicates worsening.
Time Frame
baseline, 52 weeks
Title
Change From Baseline in Mean Analgesic Score
Description
The analgesic score indicates the types of pain medication used. The scores range as follows: 0 = none medication; 1 = minor analgesics (aspirin, NSAID, acetaminophen, propoxyphene, etc.); 2 = Tranquilizers, antidepressants, muscle relaxants, and steroids; 3 = Mild narcotics (oxycodone, meperidine, codeine, etc.); and 4 = Strong narcotics (morphine, hydromorphone, etc.). A positive change from baseline indicates worsening.
Time Frame
baseline, 52 weeks
Title
Change From Baseline in Urinary N-telopeptide / Creatinine Ratio
Description
Urine samples were collected to obtain n-telopeptide and creatinine values.
Time Frame
baseline, 48 weeks
Title
Change From Baseline in Serum Bone Specific Alkaline Phosphatase
Description
Serum samples were collected to obtain bone specific alkaline phosphatase values.
Time Frame
baseline, 48 weeks
Title
Skeletal Morbidity Rate
Description
An SMR for a patient was defined as the "number of occurrences" of any (or a particular) SRE allowing for only 1 event in any 3-week interval, divided by the "time at risk" in years. The "number of occurrences" and the "time at risk" were counts of SRE and the time from the randomization date. Counting began from randomization in the way that every counted event was followed by a 20-day period during which no SRE was counted, nor was the time counted as "at risk". For example, if a patient had 1 SRE during the study, the "time at risk" was calculated as the total number of days in the study minus the 20-day follow-up period for that SRE. If a patient had no SRE events, the entire study period was counted as "time at risk". This SMR calculation method had the advantage of avoiding multiple counts of possibly interdependent SREs (e.g. having 1 fracture increases the probability of having a subsequent SRE).
Time Frame
52 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female patients ≥ 18 years of age. Confirmed breast cancer with bone metastasis. Pretreated with Zometa®, or Aredia (pamidronate) or all sequential regimens of both, for a minimum of 9 doses; Exclusion Criteria: Abnormal kidney function determined by serum creatinine levels. Current active dental problems including: ongoing infection of the teeth or jawbone; current exposed bone in the mouth; and current or prior diagnosis of osteonecrosis of the jaw. Recent (within 8 weeks) or planned dental or jaw surgery (e.g., extraction, implants). Diagnosis of metabolic bone disease other than osteoporosis (e.g., Paget's disease of bone). Known hypersensitivity to Zometa. Treatment with other investigational drugs within 30 days prior to randomization. Other protocol-defined exclusion criteria may have applied.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Providence Alaska Medical Center Cancer Research
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Heritage Physicians Group Oncology
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
The Center for Chest Care
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72764
Country
United States
Facility Name
Pacific Cancer Medical Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
South Bay Oncology Hematology Partners
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
Bay Area Cancer Research
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Pacific Coast Hem/Onc
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Wilshire Oncology Medical Group
City
La Verne
State/Province
California
ZIP/Postal Code
91750
Country
United States
Facility Name
Kenmar Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
North Valley Hematology/Oncology Providence Holy Cross Medical
City
Northridge
State/Province
California
ZIP/Postal Code
91328
Country
United States
Facility Name
Medical Oncology Care Associates
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Ventura County Hematology and Oncology
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
The Office of Dr. Swarna Chanduri, MD
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Access Clinical Research
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Cancer and Blood of the Desert
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California at Los Angeles
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Denver Health Medical Center CACZ885M2301
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204-4507
Country
United States
Facility Name
Eastern Connecticut Hematology & Oncology Associates
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Georgetown University/Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007-2197
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Baptist Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Pasco Hernando Oncology
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
The Office of Dr. Elizabeth Tan-Chiu, MD PA
City
Planatation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Suburban Hematology-Oncology
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Evanston Northwestern Healthcare Medical Group
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Edward Cancer Center
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
Midwest Cancer Research Group
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Investigative Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
Cancer Care Center
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Associated Physicians & Surgeons Clinic
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47804
Country
United States
Facility Name
Medical Associates Clinic, PC
City
Dubuque
State/Province
Iowa
ZIP/Postal Code
52001
Country
United States
Facility Name
University of Iowa Health Care
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1091
Country
United States
Facility Name
Siouxland Hematology-Oncology Associates LLP
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Cotton O'Neil Oncology Clinic
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Cancer Center of Kansas
City
Witchita
State/Province
Kansas
ZIP/Postal Code
67214-3728
Country
United States
Facility Name
Kentucky Lung Clinic & Kentucky Sleep Clinic
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Lexington Oncology Associates
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Cabrini Center for Cancer Care
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Southwest Oncology Associates Ltd.
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Greenbaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1595
Country
United States
Facility Name
St. Agnes Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
The Harry and Jeanette Weinberg Cancer Institute at Franklin
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Center for Cancer & Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Frederick Memorial Hospital
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21701
Country
United States
Facility Name
Caritas Holy Family Hospital
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
University of Michigan Clinical Trials Office
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hospital Oncology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Oncology Care Associates, PLLC
City
St. Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
St. Luke's Hospital and Health Network
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Fairview Clinical Trial Services
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Facility Name
Univ. of Minnesota Cancer Center 420 Delaware St.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Hubert H. Humphrey Cancer Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Jackson Oncology Associates
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Capitol Comprehensive Cancer Care Clinic
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
The Center for Cancer Care and Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Nebraska Hematology-Oncology PC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Nevada Cancer Centers 2851 North Tenaya Way
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Center for Cancer and Hematologic Disease
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Facility Name
Saint Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Somerset Hematology Oncology Associates
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States
Facility Name
Advanced Oncology Associates
City
Armonk
State/Province
New York
ZIP/Postal Code
10504
Country
United States
Facility Name
Arena Oncology Associates, PC
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Benedictine Hospital
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Jmaes P. Wilmot Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Alamance Regional Medical Cancer Center
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27215
Country
United States
Facility Name
Northeast Oncology Associates Suite 250
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Barberton Citizens Hospital
City
Barberton
State/Province
Ohio
ZIP/Postal Code
44203
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Ohio Cancer Specialists
City
Mansfield
State/Province
Ohio
ZIP/Postal Code
44907
Country
United States
Facility Name
Hematology/Oncology Consultants Inc.
City
West Worthington
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Trilogy Cancer Care
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Bay Area Hospital - Pharmacy
City
Coos Bay
State/Province
Oregon
ZIP/Postal Code
97420
Country
United States
Facility Name
The Corvallis Clinic, P.C.
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Lancaster Cancer Center
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Facility Name
U of Pittsburgh Cancer Institute Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Guthrie Cancer Center
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Mainline Oncology Hematology Assoc.
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
M. Francisco Gonzalez, MD., FACP
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Santee Hematology/Oncology
City
Sumter
State/Province
South Carolina
ZIP/Postal Code
29150
Country
United States
Facility Name
MD Anderson Cancer Center/University of Texas 1155 Herman Pressler Street
City
Houston
State/Province
Texas
ZIP/Postal Code
77031
Country
United States
Facility Name
Cancer Centers of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Providence Everett Medical Clinic
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Seattle Cancer Care Alliance Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Rockwood Clinic Rockwood Clinic, PS
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28125763
Citation
Hortobagyi GN, Van Poznak C, Harker WG, Gradishar WJ, Chew H, Dakhil SR, Haley BB, Sauter N, Mohanlal R, Zheng M, Lipton A. Continued Treatment Effect of Zoledronic Acid Dosing Every 12 vs 4 Weeks in Women With Breast Cancer Metastatic to Bone: The OPTIMIZE-2 Randomized Clinical Trial. JAMA Oncol. 2017 Jul 1;3(7):906-912. doi: 10.1001/jamaoncol.2016.6316.
Results Reference
derived
Links:
URL
http://www.novartisclinicaltrials.com/webapp/etrials/searchTrial.do?trialID=513
Description
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
URL
http://www.breastcancerresearchstudy.com
Description
Breast Cancer

Learn more about this trial

Continued Efficacy and Safety of Zoledronic Acid (q 4 Wks vs. q 12 Wks) in the 2nd Year of Treatment in Patients With Bone Metastases From Breast Cancer

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