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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Multiple Myeloma, Breast Cancer

Intervention / Treatment
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* Drug: Zoledronic acid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zometa q 4 weeks<br> | Drug: Zoledronic acid<br> <br> * Other names: ZOL446;|
| Active Comparator: Zometa q 12 weeks<br> | Drug: Zoledronic acid<br> <br> * Other names: ZOL446;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple myeloma, breast cancer, zoledronic acid, pharmacokinetics