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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00424983

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

2.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Nov 1, 2006

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zometa q 4 weeks	Drug: Zoledronic acid Other Names: ZOL446
Active Comparator: Zometa q 12 weeks	Drug: Zoledronic acid Other Names: ZOL446

Arm

Intervention/Treatment

Experimental: Zometa q 4 weeks

Drug: Zoledronic acid

Other Names:

ZOL446

Active Comparator: Zometa q 12 weeks

Drug: Zoledronic acid

Other Names:

ZOL446

Outcome Measures

Primary Outcome Measures

Sequential plasmas concentrations of zoledronic acid collected at 13 study visits between visit 2 to visit 17 [every four (4) weeks]
Sequential urine concentrations of zoledronic acid collected at 9 study visits between visit 2 to visit 13 [every four (4) weeks]

Secondary Outcome Measures

Pharmacodynamic outcomes will be measured by the concentration of bone resorption markers at all visits. [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. [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Oncotherapeutics	West Hollywood	California	United States	90069
2	Rocky Mountain Cancer Centers RMCC	Greenwood Village	Colorado	United States
3	Norwalk Hospital	Norwalk	Connecticut	United States	06856
4	Hillman Cancer Center	Pittsburgh	Pennsylvania	United States	15232
5	Huntsman Cancer Institute Univ. of Utah	Salt Lake City	Utah	United States	84112-0550
6	University of Vermont Fletcher Allen Health Care	Burlington	Vermont	United States	05404
7	Virginia Cancer Institute Virginia Cancer Center	Richmond	Virginia	United States	23230