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Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only

This study has been completed.
Information provided by (Responsible Party):
Amgen Identifier:
First received: July 30, 2009
Last updated: December 19, 2013
Last verified: December 2013
The purpose of this study is to describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.

Condition Intervention Phase
Bone Metastases in Men With Hormone-Refractory Prostate Cancer Bone Metastases in Subjects With Advanced Breast Cancer Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma Drug: amg 162 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab in the Treatment of Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Number of Participants Survived [ Time Frame: 2 years ]

Enrollment: 35
Study Start Date: July 2009
Study Completion Date: April 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: amg 162
120 mg SC injection of denosumab Q4W until the subject has access to commercially available product or for up to 2 years, which ever comes first.


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

Inclusion Criteria:

  • Subjects currently enrolled in study 20050103, 20050136, or 20050244
  • Subjects must sign the informed consent before any study specific procedures are performed

Exclusion Criteria:

  • Developed sensitivity to mammalian cell derived drug products during the 20050103, 20050136, or 20050244 study
  • Currently receiving any unapproved investigational product other than denosumab
  • Subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment
  • Subject (male or female) is not willing to use 2 highly effective contraception during treatment and for 7 months (women) or 10 months (men) after the end of treatment
  • Male subject with a pregnant partner who is not willing to use a condom during treatment and for additional 10 months after the end of treatment
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00950911

Czech Republic
Research Site
Jindrichuv Hradec, Czech Republic, 377 01
Research Site
Kromeriz, Czech Republic, 767 55
Research Site
Olomouc, Czech Republic, 775 20
Research Site
Praha 1, Czech Republic, 110 00
Research Site
Praha 4, Czech Republic, 140 00
Research Site
Praha 4, Czech Republic, 140 44
Research Site
Praha 5, Czech Republic, 150 06
Research Site
Praha 6, Czech Republic, 160 00
Research Site
Zlin, Czech Republic, 762 75
United Kingdom
Research Site
Chichester, United Kingdom, PO19 4SE
Research Site
Leeds, United Kingdom, LS9 7TF
Research Site
London, United Kingdom, SE1 9RT
Research Site
London, United Kingdom, W2 1NY
Research Site
Manchester, United Kingdom, M20 4BX
Research Site
Northwood, United Kingdom, HA6 2RN
Research Site
Peterborough, United Kingdom, PE3 9GZ
Research Site
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen Identifier: NCT00950911     History of Changes
Other Study ID Numbers: 20080540
Study First Received: July 30, 2009
Results First Received: December 17, 2012
Last Updated: December 19, 2013

Keywords provided by Amgen:
Bone metastases
Hormone-refractory prostate cancer
Multiple myeloma
Breast cancer
Advanced cancer
Prostate cancer
Zoledronic acid

Additional relevant MeSH terms:
Prostatic Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Bone Density Conservation Agents processed this record on September 21, 2017