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Cancer and Osteoporosis Research With Alendronate and Lupron (C.O.R.A.L )

NCT00236002 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2009-08-12

No results posted yet for this study

Summary

Multi-center,double blind randomized phase III placebo controlled study in 250 men with histologically proven prostate cancer with out bone metastases who are beginning ADT therapy and who will receive concomitant treatment with either oral Fosamax 70mg once weekly or placebo for one year.These men will be treated and follow up for one year,during which time changes in BMD, markers of bone resorption and formation will be monitored.All patients will receive calcium and vitamin D through out the study.

Conditions

Interventions

DRUG

Alendronate

Alendronate 70mgm once a week for one year

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Merck Frosst Canada Ltd.

    collaborator INDUSTRY

  • Canadian Urology Research Consortium

    lead OTHER

Principal Investigators

  • Lesley Carr, M.D. · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2007-11-30
Completion
2009-08-31

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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 NCT00236002 on ClinicalTrials.gov