Study to Assess Efficacy and Safety of Zoledronic Acid and the Value of Markers of Bone Resorption in the Prediction of Bone Metastases and Cancer Treatment-induced Bone Loss (CTIBL) in Patients With Prostate Cancer on Hormone Therapy

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to investigate whether blood markers can be used to predict the development of bone metastases and to assess the efficacy and safety of zoledronic acid in cancer treatment induced bone loss.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Diphosphonates; Hormones; Zoledronic Acid

Criteria

Inclusion Criteria:

• All stages of prostate cancer without bone metastases

• No evidence of severe osteoporosis

• ECOG performance status 0, 1 or 2

Exclusion Criteria:

• Surgery / fracture at the lumbosacral spine, bilateral hip implants

• Evidence of metabolic bone diseases,

• Treatment with bisphosphonates or calcitonin within the previous year or chronic systemic corticosteroid treatment

• Abnormal kidney or liver function

• Other cancers within the last 5 years

Other protocol-defined exclusion criteria may apply.