Double-Blind Study of Denosumab Compared With Zoledronic Acid in the Treatment of Bone Metastases in Men With Hormone-Refractory Prostate Cancer - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00321620

Purpose

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

Condition	Intervention	Phase
Bone Metastases in Men With Hormone-Refractory Prostate Cancer	Drug: denosumab Drug: zoledronic acid	Phase III

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Zoledronic acid Immunoglobulins Globulin, Immune Denosumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official 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

Further study details as provided by Amgen:

Primary Outcome Measures:

Time to the first on-study SRE (non-inferiority) [ Time Frame: Onset of event for 745 subjects ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time to the first on-study SRE (superiority) [ Time Frame: Onset of event for 745 subjects ] [ Designated as safety issue: Yes ]
Time to the first-and-subsequent on-study SRE (superiority, using multiple event analysis) [ Time Frame: Onset of first and subsequent event ] [ Designated as safety issue: Yes ]
Subject incidence of treatment-emergent adverse events [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
Changes in laboratory values [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
Incidence of anti-denosumab antibody (binding and neutralizing) formation [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1700
Study Start Date:	April 2006
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
denosumab placebo with active zoledronic acid: Active Comparator	Drug: zoledronic acid zoledronic acid is a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate.
denosumab with zoledronic acid placebo: Placebo Comparator	Drug: denosumab Denosumab is a fully human monoclonal antibody with a high affinity and specificity for RANKL that can bind and neutralize the activity of human RANKL similar to the action of native osteoprotegerin (OPG) and its engineered variants

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321620

Contacts

Contact: Amgen Call Center

866-572-6436

Show 416 Study Locations

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20050103
Study First Received:	May 2, 2006
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00321620
Health Authority:	Italy: Ministry of Health; Latvia: State Agency of Medicines; Lithuania: Ministry of Health; Mexico: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; Netherlands: Medicines Evaluation Board; Norway: Norwegian Medicines Agency; Panama: Ministry of Health, Peru: Ministry of Health; Poland: Drug Institut; Portugal: National Institute of Pharmacy and Medicines; Romania: Ministry of Health and the Family; Russia: Ministry of Health; Slovakia: Ministry of Health; South Africa: Department of Health; Spain: Spanish Drug Agency; Sweden: Medical Products Agency; Switzerland: Agency for Therapeutic Products; Turkey: Ministry of Health; Ukraine: Ministry of Health; Argentina: Ministry of Health; Australia: Therapeutic Goods Administration; Austria: Secretariat of Health; Belgium: Pharmaceutical Inspectorate; Brazil: Ministry of Health; Bulgaria: Ministry of Health; Canada: Health Products and Food Branch; Chile: Health Ministry; Czech Republic: State Institute for Drug Control; Denmark: Ministry of Health; Estonia: State Agency of Medicines; France: Ministry of Health; Germancy: Federal Institute for Drugs and Medical Devices; Greece: National Organization for Medicines; Guatemala: Ministry of Health; Hungary: Ministry of Health, Social and Family Affairs; Israel: Ministry of Health

Keywords provided by Amgen:

Bone metastases
Hormone-refractory prostate cancer
Skeletal

Fractures
Compressions
Bisphosphonates

Study placed in the following topic categories:

Zoledronic acid
Bone Neoplasms
Genital Neoplasms, Male
Prostatic Diseases
Hematologic Diseases
Fractures, Bone
Bone neoplasms
Urogenital Neoplasms
Genital Diseases, Male

Bone Diseases
Antibodies, Monoclonal
Antibodies
Diphosphonates
Musculoskeletal Diseases
Neoplasm Metastasis
Bone Marrow Diseases
Prostatic Neoplasms
Immunoglobulins

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes

Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009