Comparison of Zometa Retention and Effect in Multiple Myeloma and Breast Cancer
NCT ID: NCT00760370
Last Updated: 2011-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2008-12-31
2011-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Zoledronic Acid
4 mg intravenous (iv), one treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
No
Sponsors
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Odense University Hospital
OTHER
Novartis
INDUSTRY
Vejle Hospital
OTHER
Responsible Party
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Principal Investigators
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Torben Plesner, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Vejle Hospital
Locations
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Odense University Hospital
Odense, , Denmark
Vejle Hospital
Vejle, , Denmark
Countries
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References
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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. doi: 10.1359/JBMR.050522. Epub 2005 May 31.
Other Identifiers
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2007-003777-13
Identifier Type: -
Identifier Source: secondary_id
2007-003777-13
Identifier Type: -
Identifier Source: org_study_id