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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00424983
Recruitment Status : Completed
First Posted : January 22, 2007
Last Update Posted : September 9, 2014
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Breast Cancer Drug: Zoledronic acid Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : November 2006
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Arm Intervention/treatment
Experimental: Zometa q 4 weeks Drug: Zoledronic acid
Other Name: ZOL446

Active Comparator: Zometa q 12 weeks Drug: Zoledronic acid
Other Name: ZOL446

Primary Outcome Measures :
  1. Sequential plasmas concentrations of zoledronic acid collected at 13 study visits between visit 2 to visit 17 [ Time Frame: every four (4) weeks ]
  2. Sequential urine concentrations of zoledronic acid collected at 9 study visits between visit 2 to visit 13 [ Time Frame: every four (4) weeks ]

Secondary Outcome Measures :
  1. Pharmacodynamic outcomes will be measured by the concentration of bone resorption markers at all visits. [ Time Frame: every four (4) weeks ]
  2. 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. [ Time Frame: 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 ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00424983

United States, California
West Hollywood, California, United States, 90069
United States, Colorado
Rocky Mountain Cancer Centers RMCC
Greenwood Village, Colorado, United States
United States, Connecticut
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
United States, Pennsylvania
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Utah
Huntsman Cancer Institute Univ. of Utah
Salt Lake City, Utah, United States, 84112-0550
United States, Vermont
University of Vermont Fletcher Allen Health Care
Burlington, Vermont, United States, 05404
United States, Virginia
Virginia Cancer Institute Virginia Cancer Center
Richmond, Virginia, United States, 23230
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Chair: Novartis Novartis

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00424983     History of Changes
Other Study ID Numbers: CZOL446E2105
2007-004719-73 ( EudraCT Number )
First Posted: January 22, 2007    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: September 2014

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Multiple myeloma
breast cancer
zoledronic acid

Additional relevant MeSH terms:
Breast Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs