Comparison of Zometa Retention and Effect in Multiple Myeloma and Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00760370|
Recruitment Status : Completed
First Posted : September 26, 2008
Last Update Posted : December 7, 2011
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Breast Cancer||Drug: Zoledronic Acid||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bone Retention of Bisphosphonate (Zometa) in Patients With Multiple Myeloma or Breast Cancer With Metastases to Bone|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
- Drug: Zoledronic Acid
4 mg intravenous (iv), one treatmentOther Name: Zometa
- Amount of Zometa retained in body [ Time Frame: 48 hrs ]
- Changes in bone markers [ Time Frame: 14 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00760370
|Odense University Hospital|
|Odense, Denmark, 5000|
|Vejle, Denmark, 7100|
|Principal Investigator:||Torben Plesner, MD, PhD||Vejle Hospital|