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:
Novartis Pharmaceuticals
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
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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:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Zoledronic acid
U.S. FDA Resources
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
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 June 18, 2013