Breast Cancer Clinical Trial
Official title:
Bone Retention of Bisphosphonate (Zometa) in Patients With Multiple Myeloma or Breast Cancer With Metastases to Bone
Verified date | December 2011 |
Source | Vejle Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Medicines Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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) |
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Odense University Hospital | Odense | |
Denmark | Vejle Hospital | Vejle |
Lead Sponsor | Collaborator |
---|---|
Vejle Hospital | Novartis, Odense University Hospital |
Denmark,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Amount of Zometa retained in body | 48 hrs | No | |
Secondary | Changes in bone markers | 14 days | No |
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