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A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01350934
First received: May 9, 2011
Last updated: August 6, 2014
Last verified: August 2014
Results First Received: June 20, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Osteoporosis, Postmenopausal
Interventions: Drug: alendronate 70-mg/vitamin D3 5600 IU combination tablet (Fosamax Plus)
Drug: Calcitriol
Dietary Supplement: Calcium 500 mg

  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
Fosamax Plus Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
Calcitriol Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).

Participant Flow for 2 periods

Period 1:   Base Study
    Fosamax Plus     Calcitriol  
STARTED     111     108  
COMPLETED     100     105  
NOT COMPLETED     11     3  
Adverse Event                 6                 0  
Lost to Follow-up                 1                 0  
Protocol Violation                 1                 1  
Withdrawal by Subject                 1                 2  
Non-Compliance With Study Drug                 2                 0  

Period 2:   Extension Study
    Fosamax Plus     Calcitriol  
STARTED     100     105  
COMPLETED     95     101  
NOT COMPLETED     5     4  
Adverse Event                 2                 1  
Lost to Follow-up                 2                 0  
Protocol Violation                 1                 1  
Lack of Efficacy                 0                 1  
Withdrawal by Subject                 0                 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.
Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for analyses that required baseline data.

Reporting Groups
  Description
Fosamax Plus Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
Calcitriol Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
Total Total of all reporting groups

Baseline Measures
    Fosamax Plus     Calcitriol     Total  
Number of Participants  
[units: participants]
  101     107     208  
Age  
[units: Years]
Mean ± Standard Deviation
  65.6  ± 7.97     64.8  ± 7.44     65.2  ± 7.69  
Gender  
[units: Participants]
     
Female     101     107     208  
Male     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Base Study: Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 6   [ Time Frame: Baseline and Month 6 ]

2.  Primary:   Extension Study: Percentage Change From Baseline in Lumbar Spine BMD at Month 12   [ Time Frame: Baseline and Month 12 ]

3.  Secondary:   Base Study: Percentage Change From Baseline in Serum Procollagen Type 1 N-Terminal Propeptide (s-P1NP) at Month 6   [ Time Frame: Baseline and Month 6 ]

4.  Secondary:   Base Study: Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 6   [ Time Frame: Baseline and Month 6 ]

5.  Secondary:   Extension Study: Percentage Change From Baseline in s-P1NP at Month 12   [ Time Frame: Baseline and Month 12 ]

6.  Secondary:   Extension Study: Percentage Change From Baseline in s-CTx at Month 12   [ Time Frame: Baseline and Month 12 ]

7.  Other Pre-specified:   Extension Study: Percentage of Participants With Serum 25-Hydroxyvitamin (OH) D <20 ng/mL at Month 12   [ Time Frame: Baseline and 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: Senior Vice President, Global Clinical Development
Organization: Merck Sharpe & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01350934     History of Changes
Other Study ID Numbers: 0217A-264
Study First Received: May 9, 2011
Results First Received: June 20, 2014
Last Updated: August 6, 2014
Health Authority: China: Food and Drug Administration