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

Novartis

Status and phase: Completed; Phase 1

Conditions: Breast Cancer; Multiple Myeloma

Treatments: Drug: Zoledronic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00424983

2007-004719-73 (EudraCT Number)

CZOL446E2105

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Zometa q 4 weeks

Experimental group

Treatment:

Drug: Zoledronic acid

Zometa q 12 weeks

Active Comparator group

Treatment:

Drug: Zoledronic acid