Denosumab Adherence Preference Satisfaction Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00518531
First received: August 16, 2007
Last updated: January 22, 2014
Last verified: January 2014
Results First Received: July 1, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Osteoporosis
Interventions: Drug: alendronate
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
First subject enrolled 03-Oct-07, last subject enrolled 25-Jun-08; First subject crossovered 22-May-08, last subject crossovered 25-Jun-09;

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
Alendronate in Period 1 Then Denosumab in Period 2 Alendronate 70 mg orally once a week (QW) for 1 year (treatment period 1) followed by Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 2).
Denosumab in Period 1 Then Alendronate in Period 2 Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 1) followed by Alendronate 70 mg orally once a week for 1 year (treatment period 2).

Participant Flow for 2 periods

Period 1:   Treatment Period 1
    Alendronate in Period 1 Then Denosumab in Period 2     Denosumab in Period 1 Then Alendronate in Period 2  
STARTED     124     126  
Received Treatment     119     124  
COMPLETED     106     114 [1]
NOT COMPLETED     18     12  
Adverse Event                 5                 0  
Lost to Follow-up                 5                 3  
Physician Decision                 1                 0  
Protocol Violation                 2                 0  
Withdrawal by Subject                 4                 6  
Early crossover                 1                 3  
[1] Participants who completed Treatment Period 1 may choose not to start Treatment Period 2

Period 2:   Treatment Period 2
    Alendronate in Period 1 Then Denosumab in Period 2     Denosumab in Period 1 Then Alendronate in Period 2  
STARTED     106     115 [1]
Received Treatment     106     110  
COMPLETED     103     95  
NOT COMPLETED     3     20  
Withdrawal by Subject                 0                 8  
Complete out of scheduled visit window                 1                 2  
Adverse Event                 1                 7  
Protocol-specified criteria                 0                 1  
Non-compliance                 1                 2  
[1] Participants can start Treatment Period 2 without completing Treatment Period 1.



  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
Alendronate in Period 1 Then Denosumab in Period 2 Alendronate 70 mg orally once a week for 1 year (treatment period 1) followed by Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 2).
Denosumab in Period 1 Then Alendronate in Period 2 Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 1) followed by Alendronate 70 mg orally once a week for 1 year (treatment period 2).
Total Total of all reporting groups

Baseline Measures
    Alendronate in Period 1 Then Denosumab in Period 2     Denosumab in Period 1 Then Alendronate in Period 2     Total  
Number of Participants  
[units: participants]
  124     126     250  
Age  
[units: Years]
Mean ± Standard Deviation
  65.3  ± 7.7     65.1  ± 7.6     65.2  ± 7.6  
Gender  
[units: Participants]
     
Female     124     126     250  
Male     0     0     0  
Race/Ethnicity, Customized  
[units: Participants]
     
White or Caucasian     119     115     234  
Black or African American     2     2     4  
Hispanic or Latino     1     6     7  
Asian     1     3     4  
Japanese     1     0     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Adherence With Treatment in the First Treatment Period   [ Time Frame: Treatment period 1 (Month 1 to Month 12) ]

2.  Secondary:   Adherence With Treatment in the Second Treatment Period   [ Time Frame: Treatment period 2 (Months 13 to 24) ]

3.  Secondary:   Compliance With Treatment in the First Treatment Period   [ Time Frame: Treatment period 1 (Month 1 to Month 12) ]

4.  Secondary:   Compliance With Treatment in the Second Treatment Period   [ Time Frame: Treatment period 2 (Month 13 to Month 24) ]

5.  Secondary:   Persistence With Treatment in the First Treatment Period   [ Time Frame: Treatment period 1 (Month 1 to Month 12) ]

6.  Secondary:   Persistence With Treatment in the Second Treatment Period   [ Time Frame: Treatment period 2 (Month 13 to Month 24) ]

7.  Secondary:   Time to Non-adherence to Alendronate Treatment in the First Treatment Period   [ Time Frame: Treatment Period 1 (Month 1 to Month 12) ]

8.  Secondary:   Time to Non-adherence to Alendronate Treatment in the Second Treatment Period   [ Time Frame: Treatment Period 2 (Month 13 to Month 24) ]

9.  Secondary:   Time to Non-compliance to Alendronate Treatment in the First Treatment Period   [ Time Frame: Treatment period 1 (Month 1 to Month 12) ]

10.  Secondary:   Time to Non-compliance to Alendronate Treatment in the Second Treatment Period   [ Time Frame: Treatment period 2 (Month 13 to Month 24) ]

11.  Secondary:   Time to Non-persistence to Alendronate Treatment in the First Treatment Period   [ Time Frame: Treatment period 1 (Month 1 to Month 12) ]

12.  Secondary:   Time to Non-persistence to Alendronate Treatment in the Second Treatment Period   [ Time Frame: Treatment period 2 (Month 13 to Month 24) ]

13.  Secondary:   Overall Satisfaction to Study Treatment   [ Time Frame: End of treatment period 1 (Month 12) ]

14.  Secondary:   Beliefs About Medicines Questionnaire (BMQ): Necessity Score   [ Time Frame: Baseline, Month 6, Month 12, Month 18 and Month 24 ]

15.  Secondary:   Beliefs About Medicines Questionnaire (BMQ) Concern Score   [ Time Frame: Baseline and Month 6, Month 12, Month 18, and Month 24 ]

16.  Secondary:   Beliefs About Medicines Questionnaire (BMQ) Preference Score   [ Time Frame: Baseline and Month 6, Month 12, Month 18, and Month 24 ]

17.  Secondary:   Medication Adherence Rating Scale (MARS) to Alendronate in the First Treatment Period   [ Time Frame: Month 6, Month 12 (treatment period 1) ]

18.  Secondary:   Medication Adherence Rating Scale (MARS) to Alendronate in the Second Treatment Period   [ Time Frame: Month 18, Month 24 (treatment period 2) ]


  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


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00518531     History of Changes
Other Study ID Numbers: 20060232, DAPS
Study First Received: August 16, 2007
Results First Received: July 1, 2010
Last Updated: January 22, 2014
Health Authority: Canada: Health Canada
Canada: Institutional Review Board
United States: Food and Drug Administration
United States: Institutional Review Board