drugset / Trial / NCT00236002
Cancer and Osteoporosis Research With Alendronate and Lupron (C.O.R.A.L )
Phase 3
Terminated
182 enrolled
Canadian Urology Research Consortium
Abbott · collabMerck Frosst Canada Ltd. · collab
RandomizedParallel-groupDouble-blindPrevention
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.
Timeline
- Start
- 2005-07
- Primary completion
- 2007-11
- Completion
- 2009-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Alendronic Acid | Small molecule | 70 mg | Oral |