Efficacy Study of Risedronate to Prevent Cancer Treatment-Induced Bone Loss in Prostate Cancer

NCT00426777 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2012-02-03

No results posted yet for this study

Summary

Prostate cancer patients treated with LHRH agonists (e.g., leuprolide) lose bone mineral density. This is similar to post-menopausal osteoporosis. Risedronate is approved to prevent osteoporosis. We hypothesize that risedronate may also be effective in prostate cancer patients treated with LHRH agonists.

Conditions

Interventions

DRUG

risedronate

risedronate 35mg tablet, weekly for 12 months

DRUG

risedronate

35mg weekly

DRUG

Control

risedronate-matched placebo weekly

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY
  • CMX Research

    lead OTHER

Principal Investigators

  • Richard W Casey, M.D. · CMX Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-01-31
Completion
2009-02-28

Countries

  • Canada

Study Locations

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Entities

Companies

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 NCT00426777 on ClinicalTrials.gov