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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

NCT00365105 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2024-09-20

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • NRG Oncology

    collaborator OTHER

  • Radiation Therapy Oncology Group

    lead NETWORK

Principal Investigators

  • Michael J. Seider, MD, PhD, FACR · Summa Center for Cancer Care at Akron City Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-11
Primary Completion
2012-01-31
Completion
2017-02-27

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00365105 on ClinicalTrials.gov