A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00936897
First received: July 9, 2009
Last updated: February 5, 2013
Last verified: February 2013
Results First Received: October 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Postmenopausal Osteoporosis
Interventions: Drug: Ibandronate
Drug: Denosumab

  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 randomized from 29 July 2009 through 5 November 2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Denosumab 60 mg SC Q6M Denosumab 60 mg subcutaneous once every 6 months
Ibandronate 150 mg PO QM Ibandronate 150 mg oral monthly

Participant Flow:   Overall Study
    Denosumab 60 mg SC Q6M     Ibandronate 150 mg PO QM  
STARTED     417 [1]   416 [1]
COMPLETED     398     356  
NOT COMPLETED     19     60  
Withdrawal by Subject                 9                 19  
Adverse Event                 4                 13  
Other                 3                 9  
Lost to Follow-up                 1                 10  
Administrative Decision                 1                 2  
Protocol Violation                 1                 1  
Ineligibility Determined                 0                 3  
Noncompliance                 0                 2  
Death                 0                 1  
[1] Randomized



  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
Denosumab 60 mg SC Q6M Denosumab 60 mg subcutaneous once every 6 months
Ibandronate 150 mg PO QM Ibandronate 150 mg oral monthly
Total Total of all reporting groups

Baseline Measures
    Denosumab 60 mg SC Q6M     Ibandronate 150 mg PO QM     Total  
Number of Participants  
[units: participants]
  417     416     833  
Age  
[units: Years]
Mean ± Standard Deviation
  67.2  ± 8.1     66.2  ± 7.8     66.7  ± 8  
Gender, Customized  
[units: Participants]
     
Female     417     416     833  
Male     0     0     0  
Race/Ethnicity, Customized  
[units: Participants]
     
White or Caucasian     348     361     709  
Black or African American     3     4     7  
Hispanic or Latino     54     42     96  
Asian     3     4     7  
American Indian or Alaska Native     2     0     2  
Other     1     2     3  
Native Hawaiian or Other Pacific Islander     6     3     9  



  Outcome Measures
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1.  Primary:   Total Hip Bone Mineral Density Percent Change From Baseline at Month 12   [ Time Frame: Baseline to month 12 ]

2.  Secondary:   Serum Type-1 C-Telopeptide Percent Change From Baseline at Month 1   [ Time Frame: Baseline to month 1 ]

3.  Secondary:   Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12   [ Time Frame: Baseline to Month 12 ]

4.  Secondary:   Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12   [ Time Frame: Baseline to month 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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.


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: NCT00936897     History of Changes
Other Study ID Numbers: 20080562
Study First Received: July 9, 2009
Results First Received: October 31, 2012
Last Updated: February 5, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Central EC, called Comite de Protection des Personnes
Italy: COMITATO ETICO DELL´ENTE OSPEDALIERO OSPEDALI GALLIERA DI GENOVA
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité ético del Hospital Vall d'Hebron
United States: Food and Drug Administration