Comparison of Zometa Retention and Effect in Multiple Myeloma and Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Odense University Hospital
Novartis
Information provided by (Responsible Party):
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT00760370
First received: September 25, 2008
Last updated: December 6, 2011
Last verified: December 2011
  Purpose

The investigators major aim is to determine whether there is a difference in the retention of zoledronic acid in multiple myeloma patients, compared to patients with breast cancer metastasis to bone. In addition the investigators wish to analyze if the retention of zoledronic acid is correlated to the extent of bone resorption/formation, and if there is a tendency to changes in retention with sequential treatment.


Condition Intervention Phase
Multiple Myeloma
Breast Cancer
Drug: Zoledronic Acid
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bone Retention of Bisphosphonate (Zometa) in Patients With Multiple Myeloma or Breast Cancer With Metastases to Bone

Resource links provided by NLM:


Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Amount of Zometa retained in body [ Time Frame: 48 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in bone markers [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: December 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Zoledronic Acid
    4 mg intravenous (iv), one treatment
    Other Name: Zometa
Detailed Description:

The clinical benefit from treatment with bisphosphonates has been documented in a large number of clinical studies, and bisphosphonates are now widely used for treatment of pain and prevention of bone fractures or vertebral collapse for example in patients with cancer metastasis to bone or multiple myeloma.

Repeated intravenous administration of the more potent bisphosphonates (pamidronate and zoledronic acid) are often used for treatment of osteolytic disease caused by disseminated cancer or multiple myeloma, while the less potent oral bisphosphonates are often prescribed for treatment of benign osteoporosis. The recommended dose and time schedule for treatment with the more potent bisphosphonates is based on concerns of avoiding toxicity and at the same time obtaining maximal clinical benefit. Clinical studies in multiple myeloma and bone metastasis show significant activity of pamidronate (90 mg by iv infusion during 2-4 hours) or zoledronic acid (4 mg iv during 15 min) repeated every 4 weeks after a treatment period of 9 months and beyond, but the optimal duration of treatment is not known. This is a particular important issue since the use of potent bisphosphonates have been brought in connection with osteonecrosis.

In the present study we will compare the retention of Zometa with the effect on bone markers in patients with multiple myeloma or breast cancer with metastases to bone.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with breast cancer and metastases to bone.
  • Patients diagnosed with multiple myeloma.
  • Patients who are scheduled to receive Zometa.
  • Post-menopausal women (at least 10 months since last period).
  • Newly diagnosed patients must have clear signs of osteolysis.

Exclusion Criteria:

  • Anti-estrogen treatment.
  • Patients given chemotherapy during or less than 7 days before study begin.
  • Patients receiving glucocorticoids less than 5 days prior to study begin or during the study period (14 days)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760370

Locations
Denmark
Odense University Hospital
Odense, Denmark, 5000
Vejle Hospital
Vejle, Denmark, 7100
Sponsors and Collaborators
Vejle Hospital
Odense University Hospital
Novartis
Investigators
Principal Investigator: Torben Plesner, MD, PhD Vejle Hospital
  More Information

Publications:
Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT00760370     History of Changes
Other Study ID Numbers: 2007-003777-13, 2007-003777-13
Study First Received: September 25, 2008
Last Updated: December 6, 2011
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Vejle Hospital:
bone marker
bisphosphonate
Zometa
retention
breast cancer
multiple myeloma
CTX
bone specific ALP

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 August 28, 2014