MedTrace Logo

PR.7 Companion Trial: Effect of Intermittent Versus Continuous Androgen Suppression on Bone Loss and Body Composition

NCT00228124 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2006-01-26

No results posted yet for this study

Summary

The purpose of this study is to determine, in patients entered on the National Cancer Institute of Canada (NCIC)-PR.7 trial of intermittent versus continuous androgen ablation, whether the rates of osteoporosis, fractures, and alteration in body composition are reduced by intermittent androgen ablation.

There will be two groups of patients:

1. A cross-sectional group of 150 patients registered in PR.7 prior to January 1, 2002, randomized between intermittent androgen suppression (IAS) and continuous androgen suppression (CAS) (75 from each group). Patients who have definite bone metastases are excluded from this study. Biochemical failure does not exclude the patient.
2. A longitudinal study of 150 newly accrued patients randomized between IAS and CAS (75 from each group). These patients will have baseline evaluation of bone loss and body composition, longitudinal monitoring and follow-up on an annual basis for patients on CAS and at the end of each "off cycle" of IAS. Patients taking bisphosphonates are excluded from this study.

Conditions

Sponsors & Collaborators

  • Ontario Cancer Research Network

    lead NETWORK

Principal Investigators

  • Laurence Klotz, MD, FRCSC · Sunnybrook Health Sciences Centre

Eligibility

Min Age
0 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Completion
2008-04-30

Countries

  • Canada

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 NCT00228124 on ClinicalTrials.gov