At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases From Lung, Breast, and Prostate Cancer
In Brief
A Phase 3 clinical trial evaluating Calcium, Vitamin D, and 3 other interventions for Breast Cancer and 4 related conditions. Completed, enrolled 261 participants across 147 sites.
Detailed Summary
RATIONALE: Zoledronate, vitamin D and calcium may prevent or delay bone pain and other symptoms caused by bone metastases. It is not yet known whether giving zoledronate together with vitamin D and calcium is more effective with or without strontium 89 or samarium 153 in treating patients with bone metastases from prostate cancer, lung cancer, or breast cancer. PURPOSE: This randomized phase III trial is studying zoledronate, vitamin D, and calcium to see how well they work compared to zoledronate, vitamin D, calcium, and either strontium 89 or samarium 153 in preventing or delaying bone problems in patients with bone metastases from prostate cancer, lung cancer, or breast cancer.
Study Details
Timeline
Interventions
At least 500 mg of calcium (1 pill) by mouth daily until the study doctor thinks it is in their best interest to stop.
400 IU of vitamin D (1 pill) by mouth daily until the study doctor thinks it is in their best interest to stop.
4 mg of Zoledronic acid intravenously once a month until the study doctor thinks it is in their best interest to stop.
Single dose intravenously 1 mCi/kg body weight.
Single dose intravenously 4 mCi.