Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.

Amgen

Status and phase: Completed; Phase 3

Conditions: Bone Metastases

Treatments: Drug: Zoledronic Acid; Biological: Denosumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00330759

20050244

Details and patient eligibility

About

The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in subjects with advanced cancer and multiple myeloma (excluding breast and prostate cancer)

Enrollment: 1,779 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults with histologically/cystologically confirmed advanced cancers including solid tumors, multiple myeloma, and lymphoma
• Radiographic evidence of at least one bone metastasis (or lytic bone lesion from multiple myeloma); ECOG performance status 0, 1, or 2
• Adequate organ function

Exclusion criteria

• Diagnosis of breast or prostate cancer
• Current or prior intravenous bisphosphonate administration
• Current or prior oral bisphosphonates for bone metastases, life expectancy of less than 6 months
• Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,779 participants in 2 patient groups

zoledronic acid

Active Comparator group

Description:

denosumab placebo with active zoledronic acid

Treatment:

Drug: Zoledronic Acid

denosumab

Experimental group

Description:

active denosumab with zoledronic acid placebo

Treatment:

Biological: Denosumab