Status:
COMPLETED
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Multiple Myeloma
Breast Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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-...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00424983
Start Date
November 1 2006
End Date
November 1 2009
Last Update
December 21 2020
Active Locations (7)
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1
Oncotherapeutics
West Hollywood, California, United States, 90069
2
Rocky Mountain Cancer Centers RMCC
Greenwood Village, Colorado, United States
3
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
4
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232