CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 109 enrolled
Drug / intervention
LHRH +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00329797
NCT00329797Phase 3Completed
CompareCT.gov

A Phase III Randomized Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer

Radiation Therapy Oncology Group·interventional·Posted May 25, 2006·Updated Nov 29, 2017

In Brief

A Phase 3 clinical trial evaluating Calcium, Zoledronic acid, and 3 other interventions for Osteoporosis and Prostate Cancer. Completed, enrolled 109 participants across 88 sites in 2 countries.

Detailed Summary

RATIONALE: Zoledronate may prevent bone loss in patients with prostate cancer undergoing radiation therapy and hormone therapy. It is not yet known whether zoledronate is more effective than calcium and vitamin D alone in preventing osteoporosis and bone fractures in patients with prostate cancer. PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to calcium and vitamin D alone in preventing osteoporosis and bone fractures in patients with locally advanced nonmetastatic prostate cancer undergoing radiation therapy and hormone therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis, Prostate Cancer
CountriesCanada, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 25, 2006
Enrollment StartMar 1, 2006
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 20.1 years ago

Interventions

Calciumdietary

A single dose of 500 mg of elemental calcium orally each day for 3 years.

Zoledronic aciddietary

Patients receive IV over 15 minutes once every 6 months for 3 years. The goal dose of zoledronic acid is 4 mg, but the selection of dose is determined based on calculated creatinine clearance at baseline.

radiation therapyradiation

Patients must receive external beam irradiation, brachytherapy (HDR or LDR), or a combination of external beam irradiation and brachytherapy at the discretion of the treating physician. Dose/duration also will be at the discretion of the treating physician; however, dose will not exceed 45 Gy to 100% of the proximal femur, and no proximal femur will receive ≥ 60 Gy.

LHRHdrug

LHRH therapy must take place for a minimum of one year. Choice of LHRH agonist, dose, and duration are at the discretion of the treating physician.

Vitamin Ddietary

400 IU (10μg), orally each day for 3 years.