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)
18 Years
75 Years
Both
Multiple Myeloma, Breast Cancer
Trial Information
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)
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Sequential plasmas concentrations of zoledronic acid collected at 13 study visits between visit 2 to visit 17
Outcome Time Frame:
every four (4) weeks
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CZOL446E2105
NCT ID:
NCT00424983
Start Date:
November 2006
Completion Date:
Related Keywords:
- Multiple Myeloma
- Breast Cancer
- Multiple myeloma
- breast cancer
- zoledronic acid
- pharmacokinetics
- Breast Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| Novartis Investigative Site | Philadelphia, Pennsylvania 19111-2497 |
| Novartis Investigative Site | Sacramento, California 95817 |
| Novartis Investigative Site | Denver, Colorado 80218 |
| Novartis Investigative Site | Salt Lake City, Utah 84112 |
| Novartis Investigative Site | Norwalk, Connecticut 06856 |
| Novartis Investigative Site | Burlington, Vermont 05404 |
| Novartis Investigative Site | Richmond, Virginia 23230 |
