Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01437111
First received: September 19, 2011
Last updated: February 11, 2014
Last verified: February 2014
Results First Received: December 3, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Osteoporosis
Intervention: Drug: MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Fosamax Plus: All Participants All participants who were enrolled in the study to receive one oral combination tablet of Fosamax Plus weekly.

Participant Flow:   Overall Study
    Fosamax Plus: All Participants  
STARTED     200  
Treated Participants     198  
COMPLETED     182  
NOT COMPLETED     18  
Adverse Event                 2  
Withdrawal by Subject                 4  
Not reported                 5  
Physician Decision                 1  
Lost to Follow-up                 5  
Protocol Violation                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Baseline Analysis was performed on the All Patients as Treated (APaT) population, which included all participants who received treatment. Of 200 participants enrolled in the study, baseline data were not provided for two participants who did not receive treatment.

Reporting Groups
  Description
Fosamax Plus: All Treated Participants All participants who received at least one oral dose combination tablet of Fosamax Plus.

Baseline Measures
    Fosamax Plus: All Treated Participants  
Number of Participants  
[units: participants]
  198  
Age [1]
[units: Years]
Mean ± Standard Deviation
  68.81  ± 8.39  
Gender [2]
[units: Participants]
 
Female     193  
Male     5  
[1] Age data were not reported for 2 participants.
[2] Gender data were not reported for 2 participants.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26   [ Time Frame: Week 26 ]

2.  Secondary:   Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26   [ Time Frame: Baseline and Week 26 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01437111     History of Changes
Other Study ID Numbers: 0217A-329
Study First Received: September 19, 2011
Results First Received: December 3, 2013
Last Updated: February 11, 2014
Health Authority: Thailand: Ethical Committee