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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

September 25, 2008
December 6, 2011
December 2008
December 2011   (final data collection date for primary outcome measure)
Amount of Zometa retained in body [ Time Frame: 48 hrs ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00760370 on ClinicalTrials.gov Archive Site
Changes in bone markers [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Zometa Retention and Effect in Multiple Myeloma and Breast Cancer
Bone Retention of Bisphosphonate (Zometa) in Patients With Multiple Myeloma or Breast Cancer With Metastases to Bone

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.

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.

Interventional
Phase 2
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Multiple Myeloma
  • Breast Cancer
Drug: Zoledronic Acid
4 mg intravenous (iv), one treatment
Other Name: Zometa
Not Provided
Cremers SC, Papapoulos SE, Gelderblom H, Seynaeve C, den Hartigh J, Vermeij P, van der Rijt CC, van Zuylen L. Skeletal retention of bisphosphonate (pamidronate) and its relation to the rate of bone resorption in patients with breast cancer and bone metastases. J Bone Miner Res. 2005 Sep;20(9):1543-7. Epub 2005 May 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2011
December 2011   (final data collection date for primary outcome measure)

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)
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00760370
2007-003777-13, 2007-003777-13
Yes
Vejle Hospital
Vejle Hospital
  • Odense University Hospital
  • Novartis
Principal Investigator: Torben Plesner, MD, PhD Vejle Hospital
Vejle Hospital
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP