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.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00424983
First received: January 19, 2007
Last updated: August 15, 2012
Last verified: August 2012
  Purpose

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
Endpoint Classification: Pharmacokinetics/Dynamics Study
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 ] [ Designated as safety issue: No ]
  • Sequential urine concentrations of zoledronic acid collected at 9 study visits between visit 2 to visit 13 [ Time Frame: every four (4) weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacodynamic outcomes will be measured by the concentration of bone resorption markers at all visits. [ Time Frame: every four (4) weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: November 2006
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424983

Locations
United States, California
Novartis Investigative Site
West Hollywood, California, United States, 90069
United States, Colorado
Novartis Investigative Site
Greenwood Village, Colorado, United States
United States, Connecticut
Novartis Investigative Site
Norwalk, Connecticut, United States, 06856
United States, Pennsylvania
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States, 15232
United States, Utah
Novartis Investigative Site
Salt Lake City, Utah, United States, 84112-0550
United States, Vermont
Novartis Investigative Site
Burlington, Vermont, United States, 05404
United States, Virginia
Novartis Investigative Site
Richmond, Virginia, United States, 23230
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00424983     History of Changes
Other Study ID Numbers: CZOL446E2105, 2007-004719-73
Study First Received: January 19, 2007
Last Updated: August 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Multiple myeloma
breast cancer
zoledronic acid
pharmacokinetics

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

ClinicalTrials.gov processed this record on July 28, 2014