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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00950911
Recruitment Status : Completed
First Posted : August 3, 2009
Results First Posted : February 11, 2014
Last Update Posted : February 11, 2014
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
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
Study Start Date : July 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : April 2012

Arm Intervention/treatment
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.

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00950911

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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
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen Identifier: NCT00950911    
Other Study ID Numbers: 20080540
First Posted: August 3, 2009    Key Record Dates
Results First Posted: February 11, 2014
Last Update Posted: February 11, 2014
Last Verified: December 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:
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Prostatic Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
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
Physiological Effects of Drugs