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

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00424983

Enrollment

Registered

2007-01-22

Start date

2006-11-30

Completion date

2009-11-30

Last updated

2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Multiple Myeloma

Keywords

Multiple myeloma, breast cancer, zoledronic acid, pharmacokinetics

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.

Interventions

DRUGZoledronic acid

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026