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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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: January 19, 2007
Last updated: September 8, 2014
Last verified: September 2014
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 Intervention Phase
Multiple Myeloma
Breast Cancer
Drug: Zoledronic acid
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Sequential plasmas concentrations of zoledronic acid collected at 13 study visits between visit 2 to visit 17 [ Time Frame: every four (4) weeks ]
  • 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:
  • Pharmacodynamic outcomes will be measured by the concentration of bone resorption markers at all visits. [ Time Frame: 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. [ 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 ]

Enrollment: 18
Study Start Date: November 2006
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zometa q 4 weeks Drug: Zoledronic acid
Other Name: ZOL446
Active Comparator: Zometa q 12 weeks Drug: Zoledronic acid
Other Name: ZOL446


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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.

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Please refer to this study by its identifier: 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
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00424983     History of Changes
Other Study ID Numbers: CZOL446E2105
2007-004719-73 ( EudraCT Number )
Study First Received: January 19, 2007
Last Updated: September 8, 2014

Keywords provided by Novartis:
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 processed this record on April 28, 2017