drugset / Trial / NCT00859027

Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer

NCT00859027 ↗

Phase 4 Completed 50 enrolled UConn Health Proctor and Gamble/Aventis · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

Men treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH)-agonists such as leuprolide and goserelin for prostate cancer will become hypogonadal due to hormonal suppression and demonstrate increased bone turnover and consequent bone loss at the hip and spine. This bone loss can be prevented by treatment with 35 mg/week of risedronate.

Timeline

Start
2003-01
Primary completion
2008-03
Completion
2009-02

Outcome

Met primary endpoint

registry Risedronate 35 mg p.o. Every Week Plus Calcium and Vit D Daily vs Calcium and Vitamin D Daily (Placebo Group); p <0.01; ANOVA NCT00859027 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Risedronate Small molecule 35 mg Oral

Indications