Study of Zoledronic Acid Administered Monthly Versus Every 3 Months in Multiple Myeloma and Breast Cancer Patients Who Were Treated With Zoledronic Acid the Prior Year
A Stratified, Randomized, Open-label, Multi-center Comparative 2-arm Trial of PK, PD, and Safety of Zoledronic Acid Infusions Administered Monthly vs. Every 3-month, in Multiple Myeloma Patients With Malignant Bone Lesions, and Breast Cancer Patients With Bone Metastasis, Who Have Received 9-12* Doses of Zoledronic Acid Over the Prior Year. (*Amendment 1 Changed the Required Doses to 9-20 But Due to FDA Guidelines, the Title Has Not Been Changed)
2 other identifiers
interventional
18
1 country
7
Brief Summary
The primary objective of this study is to investigate the repeat-dose pharmacokinetic (PK) profile of zoledronic acid when administered every 4 weeks versus every 12 weeks, in patients treated with 9-20 infusions of zoledronic acid during the previous 10-15 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 multiple-myeloma
Started Nov 2006
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 19, 2007
CompletedFirst Posted
Study publicly available on registry
January 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedDecember 21, 2020
September 1, 2014
3 years
January 19, 2007
December 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Sequential plasmas concentrations of zoledronic acid collected at 13 study visits between visit 2 to visit 17
every four (4) weeks
Sequential urine concentrations of zoledronic acid collected at 9 study visits between visit 2 to visit 13
every four (4) weeks
Secondary Outcomes (2)
Pharmacodynamic outcomes will be measured by the concentration of bone resorption markers at all visits.
every four (4) weeks
Efficacy outcomes will be measured throughout the study by number and time to skeletal related events (determined by bone surveys and bone scans) as well as the measurement of pain and analgesic scores.
bone survey = every 12 weeks; bone scan = every 24 weeks; pain & analgesic scores = weekly prior to visit 8 (inclusive), every 4 weeks after visit 8
Study Arms (2)
Zometa q 4 weeks
EXPERIMENTALZometa q 12 weeks
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male or female between 18-75 years of age
- Multiple myeloma or breast cancer with bone involvement
- Treatment with zoledronic acid for bone lesions between 10-15 months prior to entry into study with a total of 9-20 infusions received.
You may not qualify if:
- Current active dental problems or recent (within 8 weeks) or planned dental or jaw surgery
- Active or uncontrolled infection, liver, or renal disease
- History of treatment with intravenous bisphosphonates
- Diagnosis of metabolic bone disorders other than osteoporosis (e.g. Paget's disease)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Oncotherapeutics
West Hollywood, California, 90069, United States
Rocky Mountain Cancer Centers RMCC
Greenwood Village, Colorado, United States
Norwalk Hospital
Norwalk, Connecticut, 06856, United States
Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Huntsman Cancer Institute Univ. of Utah
Salt Lake City, Utah, 84112-0550, United States
University of Vermont Fletcher Allen Health Care
Burlington, Vermont, 05404, United States
Virginia Cancer Institute Virginia Cancer Center
Richmond, Virginia, 23230, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
- STUDY CHAIR
Novartis
Novartis
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2007
First Posted
January 22, 2007
Study Start
November 1, 2006
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
December 21, 2020
Record last verified: 2014-09