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Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00838201
Recruitment Status : Completed
First Posted : February 6, 2009
Results First Posted : September 24, 2013
Last Update Posted : November 26, 2013
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
The purpose of this study is to describe the safety and tolerability of up to 5 years (ie, 3 years under the 20040138 Amgen study and 2 years on this study) denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab for non-metastatic prostate cancer.

Condition or disease Intervention/treatment Phase
Cancer Carcinoma Castrate-Resistant Prostate Cancer Prostate Cancer Tumors Drug: Denosumab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 384 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab (AMG 162) in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-Metastatic Prostate Cancer
Study Start Date : February 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Denosumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 Drug: Denosumab
60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18



Primary Outcome Measures :
  1. Overall Survival Through Month 24 [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be currently participating in the 20040138 Amgen study
  • Subjects must sign the informed consent before any study specific procedures are performed.

Exclusion Criteria

  • Subjects with any prior diagnosis of bone metastasis
  • Known hypocalcemia
  • Developed sensitivity to mammalian cell derived drug products during the 20040138 study
  • Currently receiving any investigational product other than denosumab or having received any investigational product during the 20040138 study
  • Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838201


  Show 74 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00838201     History of Changes
Other Study ID Numbers: 20080537
First Posted: February 6, 2009    Key Record Dates
Results First Posted: September 24, 2013
Last Update Posted: November 26, 2013
Last Verified: November 2013

Keywords provided by Amgen:
Androgen deprivation therapy for non-metastatic prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Denosumab
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents