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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1779 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-01

Study Completion Date

2011-10-01

Brief Summary

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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)

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Detailed Description

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Conditions

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Bone Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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zoledronic acid

denosumab placebo with active zoledronic acid

Group Type ACTIVE_COMPARATOR

Zoledronic Acid

Intervention Type DRUG

4 milligrams intravenous Zoledronic Acid over minimum 15 minutes every 4 weeks

denosumab

active denosumab with zoledronic acid placebo

Group Type EXPERIMENTAL

Denosumab

Intervention Type BIOLOGICAL

120 milligrams by subcutaneous injection every 4 weeks

Interventions

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Denosumab

120 milligrams by subcutaneous injection every 4 weeks

Intervention Type BIOLOGICAL

Zoledronic Acid

4 milligrams intravenous Zoledronic Acid over minimum 15 minutes every 4 weeks

Intervention Type DRUG

Other Intervention Names

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Zometa

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No