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Completed

NCT Number: 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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Breast Cancer Breast Diseases Breast Neoplasms Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Paraproteinemias Skin Diseases Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Oncotherapeutics, West Hollywood, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zoledronic acid

Drug

Other names: ZOL446

Primary outcomes

  1. Sequential plasmas concentrations of zoledronic acid collected at 13 study visits between visit 2 to visit 17

    Time frame: every four (4) weeks

  2. Sequential urine concentrations of zoledronic acid collected at 9 study visits between visit 2 to visit 13

    Time frame: every four (4) weeks

Secondary outcomes

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

    Time frame: every four (4) weeks

  2. 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 22, 2007
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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