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OpenTrials
Completed

NCT Number: NCT00321620

Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer

The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer

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Key information

Conditions

Bone Metastases Fractures, Bone Wounds and Injuries

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men >/= 18 years of age with histologically confirmed prostate cancer
  • Radiographic evidence of at least one bone metastasis
  • Failure of at least one hormonal therapy as evidenced by a rising PSA
  • Serum testosterone level of <50 ng/dL
  • ECOG PS 0, 1, or 2
  • Adequate organ function

Exclusion criteria

  • Current or prior IV bisphosphonate administration
  • Current or prior oral bisphosphonates for bone mets
  • Life expectancy of less than 6 months

Treatment and study plan

Zoledronic acid

Drug

Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC

Other names: Zometa

Denosumab

Biological

Q4W 120 mg denosumab SC and 4 mg zoledronic acid placebo IV over a minimum of 15 minutes

Primary outcomes

  1. Time to the First On-Study SRE (Non-inferiority)

    Time frame: Up to 40.5 months

    Time to the first on-study skeletal-related event (SRE) analyzed for non-inferiority. Kaplan-Meier estimates of the median and its dispersion are reported.

Secondary outcomes

  1. Time to the First On-Study SRE (Superiority)

    Time frame: Up to 40.5 months

    Time to the first on-study skeletal-related event (SRE), analyzed for superiority of denosumab. Kaplan-Meier estimates of the median and its dispersion are reported.

  2. Time to the First-And-Subsequent On-Study SRE

    Time frame: Up to 40.5 months

    Time to the first-and-subsequent on-study skeletal-related event (SRE), analyzed for superiority of denosumab using multiple event analysis, the event must occur at least 21 days after the previous SRE.

    This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men With Hormone-Refractory Prostate Cancer

Important dates

Study start
2006
Primary completion
2009
Study completion
2012
First posted
May 4, 2006
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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