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Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy

NCT00216060 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2016-05-26

Study results available
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Summary

Risedronate is an orally administered pyridinyl bisphosphonate that is 36 times more potent than pamidronate and 72 times more potent than clodronate. Four randomized, double-blind trials have been carried out in patients with postmenopausal osteoporosis. In 2 of these studies, vertebral fracture incidence was reduced by a daily dose of 5 mg risedronate by up to 65% and 49% relative to placebo after 1 and 3 years, respectively. In these trials, risedronate improved lumbar spine, femoral neck, and femoral trochanter bone mineral density (BMD) at 6 months. In addition, preclinical studies have shown that risedronate is more potent than pamidronate and clodronate in inhibiting adhesion of prostate cancer cells to bone and preventing tumor cell invasion. The incidence of osteoporosis in prostate cancer patients has been well established; therefore, it is advantageous to assess the efficacy of oral bisphosphonate therapy.

Conditions

Interventions

DRUG

Risedronate

Daily oral risedronate combined with androgen deprivation

DRUG

Placebo

Daily oral placebo combined with androgen deprivation

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Walther Cancer Institute

    collaborator OTHER

  • Hoosier Cancer Research Network

    collaborator OTHER

  • Christopher Sweeney, MBBS

    lead OTHER

Principal Investigators

  • Christopher Sweeney, M.B.B.S. · Hoosier Oncology Group, LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2008-02-29
Completion
2008-03-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00216060 on ClinicalTrials.gov