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

Novartis

Status and phase: Completed; Phase 3

Conditions: Cancer Prostate

Treatments: Drug: Zoledronic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00172055

CZOL446GBE03

Details and patient eligibility

About

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.

Enrollment: 218 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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218 participants in 1 patient group

ZOL446 (zoledronic acid)

Experimental group

Treatment:

Drug: Zoledronic acid