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A Phase IV Study of Zoledronic Acid Therapy in Patients With Bone Metastases From Breast Cancer or Hormone Resistant Prostate Cancer, or Bone Involvement From Multiple Myeloma, Assessing Long-term Efficacy and Safety


Phase 4
18 Years
N/A
Not Enrolling
Both
Bone Neoplasms

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Trial Information

A Phase IV Study of Zoledronic Acid Therapy in Patients With Bone Metastases From Breast Cancer or Hormone Resistant Prostate Cancer, or Bone Involvement From Multiple Myeloma, Assessing Long-term Efficacy and Safety

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Safety assessed by incidence of renal impairment, osteonecrosis of the Jaw (ONJ), adverse events and serious adverse events. Efficacy assessed by incidence of skeletal related events (SREs).

Outcome Time Frame:

52 weeks

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmeceuticals

Authority:

Australia: Therapeutic Goods Administration

Study ID:

CZOL446EAU22

NCT ID:

NCT00434447

Start Date:

December 2006

Completion Date:

Related Keywords:

  • Bone Neoplasms
  • Prostate Cancer
  • Breast Cancer
  • Multiple Myeloma
  • Zoledronic acid
  • Bone metastases
  • Skeletal Related Events (SREs)
  • Renal Impairment
  • Osteonecrosis of the Jaw (ONJ)
  • Bone involvement
  • Multiple Myeloma (MM)
  • Bone Neoplasms
  • Breast Neoplasms
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Neoplasm Metastasis
  • Bone Marrow Diseases

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