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

Breast Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00424983
• Other study ID #: CZOL446E2105
• Secondary ID: 2007-004719-73
• Status: Completed
• Phase: Phase 1
• Start date: November 2006
• Est. completion date: November 2009

Study information

• Verified date: September 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 9-20 infusions of zoledronic acid during the previous 10-15 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Zoledronic acid

Locations

Country	Name	City	State
United States	University of Vermont Fletcher Allen Health Care	Burlington	Vermont
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	Virginia Cancer Institute Virginia Cancer Center	Richmond	Virginia
United States	Huntsman Cancer Institute Univ. of Utah	Salt Lake City	Utah
United States	Oncotherapeutics	West Hollywood	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sequential plasmas concentrations of zoledronic acid collected at 13 study visits between visit 2 to visit 17		every four (4) weeks
Primary	Sequential urine concentrations of zoledronic acid collected at 9 study visits between visit 2 to visit 13		every four (4) weeks
Secondary	Pharmacodynamic outcomes will be measured by the concentration of bone resorption markers at all visits.		every four (4) weeks
Secondary	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

External Links

•   Results for CZOL446E2105 can be found on the Novartis Clinical Trial Results Website
•   Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.