Long Term Efficacy and Safety of Zoledronic Acid Treatment in Patients With Bone Metastases

Novartis

Status and phase: Completed; Phase 4

Conditions: Bone Neoplasms

Treatments: Drug: Zoledronic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00434447

CZOL446EAU22

Details and patient eligibility

About

This study is designed to monitor the safety and efficacy of long-term treatment with zoledronic acid by assessing the incidence of, renal impairment, osteonecrosis of the jaw(ONJ), overall safety and skeletal related events (SREs) beyond 12 months treatment

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented bone metastases from breast cancer, prostate cancer or multiple myeloma
• Prior treatment with zoledronic acid for 1-2 yrs
• Life expectancy of at least 6 months

Exclusion criteria

• Prior treatment with bisphosphonates other than zoledronic acid
• Abnormal kidney function
• Current or previous dental problems or planned dental surgery
• Pregnant or likely to become pregnant during the study

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

73 participants in 1 patient group

Zoledronic Acid

Experimental group

Description:

ZOL446

Treatment:

Drug: Zoledronic acid