Vitamin K Supplementation in Post-Menopausal Osteopenia

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00150969
First received: September 6, 2005
Last updated: November 19, 2012
Last verified: November 2012
Results First Received: January 10, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Post-Menopausal Osteoporosis
Post-Menopausal Osteopenia
Interventions: Dietary Supplement: vitamin K1 (phylloquinone)
Dietary Supplement: placebo

  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
recruitment from January 2002 to September 2006 through health fairs, community posters and advertisements.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
453 participants signed consent. 13 were not included in analysis(10 screen failure,3 drop out at baseline)

Reporting Groups
  Description
Phyloquinone 5 mg Vitamin K1
Placebo dummy pill identicle to vitamin k

Participant Flow for 2 periods

Period 1:   24 Month Main Study
    Phyloquinone     Placebo  
STARTED     217     223  
COMPLETED     198     202  
NOT COMPLETED     19     21  
Adverse Event                 3                 4  
Death                 1                 1  
Lack of Efficacy                 1                 8  
Lost to Follow-up                 3                 2  
Protocol Violation                 4                 2  
Withdrawal by Subject                 7                 4  

Period 2:   24-48 Month Extension
    Phyloquinone     Placebo  
STARTED     121     140  
COMPLETED     33     40  
NOT COMPLETED     88     100  
Withdrawal by Subject                 6                 5  
Lack of Efficacy                 0                 1  
Adverse Event                 1                 3  
Other Reason                 81                 91  



  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.
No text entered.

Reporting Groups
  Description
Phyloquinone 5 mg Vitamin K1
Placebo dummy pill identicle to vitamin k
Total Total of all reporting groups

Baseline Measures
    Phyloquinone     Placebo     Total  
Number of Participants  
[units: participants]
  217     223     440  
Age  
[units: years]
Mean ( Full Range )
  58.9  
  ( 40.1 to 80.5 )  
  59.2  
  ( 46.1 to 82.3 )  
  59.0  
  ( 40.1 to 82.3 )  
Gender [1]
[units: participant]
     
Female     217     223     440  
Male     0     0     0  
[1] All Participants were community dwelling post-menopausal women



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms.   [ Time Frame: 0 to 24 months ]

2.  Primary:   Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms.   [ Time Frame: 0 to 24 months ]

3.  Secondary:   Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms.   [ Time Frame: 0 to 24 months ]

4.  Secondary:   Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms.   [ Time Frame: 0 to 24 months ]

5.  Secondary:   Effect of Vitamin K1 Supplementation on Levels of Bone Formation Marker   [ Time Frame: 0-24 months ]

6.  Secondary:   Effect of Vitamin K1 Supplementation on Level of Bone Resorption Markers (C-telopeptide: CTX)   [ Time Frame: 0-24 months ]

7.  Secondary:   Effect of Vitamin K1 Supplementation on Percent of Carboxylation of Osteocalcin   [ Time Frame: 0 to 24 months ]

8.  Secondary:   Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms.   [ Time Frame: 0 to 48 months ]

9.  Secondary:   Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms.   [ Time Frame: 0 to 48 months ]

10.  Secondary:   Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms.   [ Time Frame: 0 to 48 months ]

11.  Secondary:   Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms.   [ Time Frame: 0 to 48 months ]

12.  Secondary:   Difference in Serious Adverse Events   [ Time Frame: up to 48 months ]

13.  Secondary:   Difference in Number of New Cancers by Treatment Arm.   [ Time Frame: up to 48 months ]

14.  Secondary:   Difference in Number of New Clinical Fractures by Treatment Arm.   [ Time Frame: up to 48 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
Originally designed as a 2-year study with BMD as primary outcome. Thus, the number of women followed to 3 and 4 years was small, and the study was not powered to examine fracture outcomes.  


Results Point of Contact:  
Name/Title: Dr. Angela M Cheung
Organization: University Health Network
phone: 416-340-4841
e-mail: jscher@uhnresearch.ca


Publications of Results:

ClinicalTrials.gov Identifier: NCT00150969     History of Changes
Other Study ID Numbers: CIHR-50422
Study First Received: September 6, 2005
Results First Received: January 10, 2012
Last Updated: November 19, 2012
Health Authority: Canada: Health Canada