A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00321464
First received: May 2, 2006
Last updated: March 25, 2014
Last verified: March 2014
Results First Received: December 10, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Supportive Care
Condition: Bone Metastases
Interventions: Biological: Denosumab
Drug: Zoledronic Acid

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from 27 April 2006 through 31 December 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2049 patients were enrolled in the study, but 3 patients were excluded from all analyses because properly documented informed consent was not obtained.

Reporting Groups
  Description
Zoledronic Acid Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
Denosumab Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks

Participant Flow:   Overall Study
    Zoledronic Acid     Denosumab  
STARTED     1020     1026  
Received Investigational Product     1014     1019  
COMPLETED     461     468  
NOT COMPLETED     559     558  
Death                 169                 174  
Disease progression                 124                 124  
Withdrawal by Subject                 117                 118  
Participant request                 57                 61  
Adverse Event                 43                 28  
Physician Decision                 15                 14  
Noncompliance                 4                 10  
Lost to Follow-up                 7                 8  
Protocol deviation                 0                 2  
Ineligibility determined                 2                 1  
Other                 21                 18  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Zoledronic Acid Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
Denosumab Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
Total Total of all reporting groups

Baseline Measures
    Zoledronic Acid     Denosumab     Total  
Number of Participants  
[units: participants]
  1020     1026     2046  
Age  
[units: Years]
Mean ± Standard Deviation
  56.6  ± 11.6     56.8  ± 11.5     56.7  ± 11.5  
Gender  
[units: Participants]
     
Female     1011     1018     2029  
Male     9     8     17  
Race/Ethnicity, Customized  
[units: Participants]
     
White or Caucasian     813     822     1635  
Black or African American     25     26     51  
Hispanic or Latino     59     59     118  
Asian     37     32     69  
Japanese     69     70     139  
Native Hawaiian or Other Pacific Islander     1     1     2  
Other     16     16     32  
Previous Skeletal-Related Event Stratification Factor  
[units: Participants]
     
Yes     373     378     751  
No     647     648     1295  
Prior Oral Bisphosphonate Use Stratification Factor  
[units: Participants]
     
Yes     38     42     80  
No     982     984     1966  
Current Chemotherapy Stratification Factor [1]
[units: Participants]
     
Yes     408     410     818  
No     612     616     1228  
Japan Stratification Factor [2]
[units: Participants]
     
Yes     67     69     136  
No     953     957     1910  
[1] Defined as within 6 weeks before randomization
[2] Participant located in Japan



  Outcome Measures
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1.  Primary:   Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority)   [ Time Frame: Up to 34 months ]

2.  Secondary:   Time to First On-Study Skeletal-Related Event (Superiority)   [ Time Frame: Up to 34 months ]

3.  Secondary:   Time to First and Subsequent On-Study Skeletal-Related Event   [ Time Frame: Up to 34 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


No publications provided by Amgen

Publications automatically indexed to this study:

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00321464     History of Changes
Other Study ID Numbers: 20050136
Study First Received: May 2, 2006
Results First Received: December 10, 2010
Last Updated: March 25, 2014
Health Authority: South Africa: Department of Health, Spain: Spanish Drug Agency, Sweden: Medical Products Agency, Switzerland: Agency for Therapeutic Products
Spain: Spanish Agency of Medicines
Spain: Spanish Drug Agency
Sweden: Central Ethics Committee
Sweden: Medical Products Agency
Switzerland: Agency for Therapeutic Products
Switzerland: Local Ethics Committee
Switzerland: Swissmedic (Swiss Agency for Therapeutic Products)
Turkey: Ministry of Health
Ukraine: Ministry of Health
Ukraine: Pharmacological Centre at the Ministry of Health of the Ukraine (Pharma Centre)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Argentina: Ministry of Health, Australia: Therapeutic Goods Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Therapeutic Goods Administration
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Bulgaria: Bulgarian Drug Agency
Bulgaria: Ministry of Health
Canada: Health Canada
Finland: Lääkelaitos
France and Sweden: European Medicines Agency
France: CCPPRB Central Ethics Committee
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
Israel: Ministry of Health
Italy: Ministry of Health
Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Evaluation Center
Latvia: State Agency of Medicines, Mexico: Ministry of Health
Lithuania: Ministry of Health
Mexico: COFEPRIS
Mexico: SSA (Secretaria de Salud Publica)
Netherlands: CCMO (Centrale Commissie Mensgebonden Onderzoek): Central Committee Human Bound Research
Netherlands: Medicines Evaluation Board
Panama: Ministry of Health
Peru: Ministry of Health
Poland: Drug Institut
Romaina: National Medicines Agency
Romania: Ministry of Health and the Family
Romania: Romanian National Drug Agency
Russia: Federal Service for Surveillance in the field of Healthcare and Social Development (a body of the Ministry of Health)
Russia: Ministry of Health
Slovakia: Ministry of Health
Slovakia: State Institiute for Drug Control
South Africa: Department of Health
Canada: Health Products and Food Branch
Canada: Institutional Review Board
Chile: Health Ministry
Estonia: State Agency of Medicines, France: Ministry of Health
EU: CHMP
European Union: European Medicines Agency