drugset / Trial / NCT00593580

Bone Health in Gynecologic Cancers-does FOSAVANCE Help?

NCT00593580 ↗

Phase 2 Completed 60 enrolled British Columbia Cancer Agency
RandomizedParallel-groupSingle-blindPrevention

Summary

Women who undergo bilateral oophorectomy and receive chemotherapy are at risk of increased bone loss. At present, despite having a risk factor profile that fits the indications for assessment and treatment there are no routine interventions in this patient population i.e., the standard treatment is no treatment. We hope to identify whether or not an intervention may be favorable in these women and change the standard of care in this vulnerable population. Hypothesis: Weekly therapy with alendronate + vitamin D (FOSAVANCE) will improve bone health as measured by DEXA scans in women with gynecologic malignancies undergoing chemotherapy as compared with patients receiving placebo.

Timeline

Start
2008-02
Primary completion
2011-06
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator alendronate/cholecalciferol Unknown 70 mg Oral
Comparator alendronate/cholecalciferol Unknown 2800 iu Oral

Indications