A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262 AM1)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00692913
First received: June 4, 2008
Last updated: August 21, 2013
Last verified: August 2013
Results First Received: July 20, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Osteoporosis
Interventions: Drug: FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol)
Dietary Supplement: Calcium Supplement 500 mg
Other: Referred-Care Model

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
FOSAVANCE 5600 Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
Referred-Care Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.

Participant Flow:   Overall Study
    FOSAVANCE 5600     Referred-Care  
STARTED     257     258  
COMPLETED     228     228  
NOT COMPLETED     29     30  
Adverse Event                 8                 4  
Lost to Follow-up                 3                 5  
Physician Decision                 2                 0  
Protocol Violation                 1                 1  
Withdrawal by Subject                 15                 20  



  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
FOSAVANCE 5600 Alendronate Sodium 70 mg/Vitamin D 5600 I.U. combination tablet once weekly plus a daily 500 mg elemental calcium supplement.
Referred-Care Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
Total Total of all reporting groups

Baseline Measures
    FOSAVANCE 5600     Referred-Care     Total  
Number of Participants  
[units: participants]
  257     258     515  
Age  
[units: years]
Mean ± Standard Deviation
  72.9  ± 5.3     72.9  ± 5.9     72.9  ± 5.6  
Gender  
[units: participants]
     
Female     257     258     515  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26   [ Time Frame: Week 26 ]

2.  Secondary:   Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio   [ Time Frame: Baseline and Week 26 ]

3.  Secondary:   Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase   [ Time Frame: Baseline and Week 26 ]

4.  Secondary:   Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52   [ Time Frame: Week 52 ]

5.  Secondary:   Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density   [ Time Frame: Baseline and Week 52 ]

6.  Secondary:   Falls Per Participant   [ Time Frame: Up to Week 52 ]

7.  Secondary:   Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio   [ Time Frame: Baseline and Week 52 ]

8.  Secondary:   Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase   [ Time Frame: Baseline and Week 52 ]


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


Publications:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00692913     History of Changes
Other Study ID Numbers: 0217A-262, 2007_653
Study First Received: June 4, 2008
Results First Received: July 20, 2011
Last Updated: August 21, 2013
Health Authority: United States: Food and Drug Administration