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

Completed · Phase 1

Conditions studied: Multiple Myeloma, Breast Cancer

In brief

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.

Key facts

Study ID

NCT00424983

Run by

Novartis Pharmaceuticals

People needed

18

Starts

2006-11-01

Expected to finish

2009-11-01

Last updated by the study team

2020-12-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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)
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Oncotherapeutics — West Hollywood, California, United States
• Rocky Mountain Cancer Centers RMCC — Greenwood Village, Colorado, United States
• Norwalk Hospital — Norwalk, Connecticut, United States
• Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• Huntsman Cancer Institute Univ. of Utah — Salt Lake City, Utah, United States
• University of Vermont Fletcher Allen Health Care — Burlington, Vermont, United States
• Virginia Cancer Institute Virginia Cancer Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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