Zoledronate in Preventing Osteoporosis and Bone Fractures in Patients With Locally Advanced Nonmetastatic Prostate Cancer Undergoing Radiation Therapy and Hormone Therapy

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.

Conditions

• Osteoporosis
• Prostate Cancer

Interventions

DIETARY_SUPPLEMENT

Calcium

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

DIETARY_SUPPLEMENT

Zoledronic acid

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

radiation therapy

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.

DRUG

LHRH

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.

DIETARY_SUPPLEMENT

Vitamin D

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Radiation Therapy Oncology Group

  lead NETWORK

Principal Investigators

• Colleen A. Lawton, MD · Medical College of Wisconsin

• Matthew R. Smith, MD · Massachusetts General Hospital

• Margaret Chamberlain-Wilmoth, PhD, MSS, RN · Carolinas Medical Center - University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-03-31

Primary Completion

2014-11-30

Completion

2014-11-30

Countries

• United States
• Canada

Study Locations