NCT00365105

Zoledronate, Vitamin D, and Calcium With or Without Strontium 89 or Samarium 153 in Preventing or Delaying Bone Problems in Patients With Bone Metastases From Prostate Cancer, Lung Cancer, or Breast Cancer

Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases From Lung, Breast, and Prostate Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: Primary * Compare the efficacy of zoledronate, vitamin D, and calcium with or without strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium, in terms of preventing or delaying the time to development of malignant skeletal-related events (SREs) (defined as a pathological bone fracture, spinal cord compression, surgery to bone, or radiation to bone) in patients with bone metastases secondary to prostate, lung, or breast cancer. Secondary * Compare the rate of SREs at 1 year in patients treated with these regimens. * Compare overall survival of patients treated with these regimens. * Compare quality of life of patients treated with these regimens. * Compare the effect of these regimens on pain control in these patients. * Evaluate resource utilization and cost effectiveness of these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to primary disease site (prostate vs breast vs lung) and number of bone metastases (≤ 2 vs \> 2). Patients are randomized to 1 of 2 treatment arms. Quality of life and pain are assessed at baseline and then at 1, 3, 6, and 12 months from start of protocol treatment. After completion of study treatment, patients are followed every 6 months.

Conditions

• Breast Cancer
• Lung Cancer
• Metastatic Cancer
• Pain
• Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Calcium	At least 500 mg of calcium (1 pill) by mouth daily until the study doctor thinks it is in their best interest to stop.
DIETARY_SUPPLEMENT	Vitamin D	400 IU of vitamin D (1 pill) by mouth daily until the study doctor thinks it is in their best interest to stop.
DRUG	zoledronic acid	4 mg of Zoledronic acid intravenously once a month until the study doctor thinks it is in their best interest to stop.
DRUG	Sm-153	Single dose intravenously 1 mCi/kg body weight.
RADIATION	Sr-89	Single dose intravenously 4 mCi.

Timeline

• Start date: 2006-07-11
• Primary completion: 2012-01-01
• Completion: 2017-02-27
• First posted: 2006-08-17
• Last updated: 2024-09-20
• Results posted: 2014-11-10

Locations

147 sites across 1 country: United States