Clinical trial NCT00424983: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Breast Cancer
Keywords: Multiple myeloma
breast cancer
zoledronic acid
pharmacokinetics
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Sequential plasmas concentrations of zoledronic acid collected at 13 study visits between visit 2 to visit 17
timeFrame: every four (4) weeks
measure: Sequential urine concentrations of zoledronic acid collected at 9 study visits between visit 2 to visit 13
timeFrame: every four (4) weeks
Secondary outcomes:
measure: Pharmacodynamic outcomes will be measured by the concentration of bone resorption markers at all visits.
timeFrame: every four (4) weeks
measure: 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.
timeFrame: 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
Other outcomes:
Locations:
city: West Hollywood
country: United States
facility: Oncotherapeutics
state: California
city: Greenwood Village
country: United States
facility: Rocky Mountain Cancer Centers RMCC
state: Colorado
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Pittsburgh
country: United States
facility: Hillman Cancer Center
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute Univ. of Utah
state: Utah
city: Burlington
country: United States
facility: University of Vermont Fletcher Allen Health Care
state: Vermont
city: Richmond
country: United States
facility: Virginia Cancer Institute Virginia Cancer Center
state: Virginia
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References: