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Vitamin K Supplementation in Post-Menopausal Osteopenia

Primary Purpose

Post-Menopausal Osteoporosis, Post-Menopausal Osteopenia

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
vitamin K1 (phylloquinone)
placebo
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-Menopausal Osteoporosis focused on measuring vitamin K, bone mineral density, post-menopausal women, randomized double blind placebo controlled trial, osteoporosis, women's health

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Postmenopausal: One year since the natural cessation of menses, or Hysterectomy with either postmenopausal status confirmed by FSH lab values, or age 55 and above AND 2. Osteopenic: T-score at baseline has to be between (and including) -1.0 and -2.0 in the lumbar spine (L1-L4), total hip or femoral neck, and the lowest reading of the above three measurements must be between -1.0 and -2.0 Exclusion Criteria: Women ever having had a fragility fracture after age 40; Women currently on anticoagulants, previously on anticoagulants in the past 3 months, or expected to be on anticoagulants in the near future; Women on hormone replacement therapy, raloxifene, bisphosphonates or calcitonin during the past 3 months; Women who have ever been on a bisphosphonate for more than 6 months; Women previously diagnosed with Paget's disease, hyperparathyroidism, hyperthyroidism or other metabolic bone diseases; Women with decompensated diseases of the liver, kidney, pancreas, lung, or heart; Women with a history of active cancer in the past 5 years; Women taking mega-doses of vitamin A (more than 10,000 iu per day) or E (more than 400 iu per day); Women involved in other clinical trials; Any women who, in the opinion of the principal investigator, is at poor medical or psychiatric risk for the study.

Sites / Locations

  • St. Michael's Hospital Health Centre
  • Mt. Sinai Hospital
  • University Health Network, Osteoporosis Department
  • Sunnybrook & Women's College Health Sciences Centre
  • University of Toronto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

phyloquinone

placebo

Arm Description

5 mg Vitamin K1

Outcomes

Primary Outcome Measures

Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms.
BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer
Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms.
BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer

Secondary Outcome Measures

Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms.
BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer
Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms.
BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer
Effect of Vitamin K1 Supplementation on Levels of Bone Formation Marker
measured by osteocalcin on elecsys platform
Effect of Vitamin K1 Supplementation on Level of Bone Resorption Markers (C-telopeptide: CTX)
measured by CTX Elisa assay on elecsys platform
Effect of Vitamin K1 Supplementation on Percent of Carboxylation of Osteocalcin
measured by osteocalcin hydroxyapatite binding assay
Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms.
BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer
Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms.
BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer
Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms.
BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer
Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms.
BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer
Difference in Serious Adverse Events
These include hospitalizations for pneumonia, heart failure, gastro-intestinal bleeding, elective and non-elective surgery, cancer and death.
Difference in Number of New Cancers by Treatment Arm.
Difference in Number of New Clinical Fractures by Treatment Arm.
these included fragility fractures

Full Information

First Posted
September 6, 2005
Last Updated
November 19, 2012
Sponsor
University Health Network, Toronto
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT00150969
Brief Title
Vitamin K Supplementation in Post-Menopausal Osteopenia
Official Title
Evaluation of the Clinical Use of Vitamin K Supplementation in Post-Menopausal Women With Osteopenia (ECKO Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether supplementation with 5 mg vitamin K daily over a 2-year period will prevent bone loss in post-menopausal women with osteopenia.
Detailed Description
Osteoporosis is major cause of morbidity and mortality in Canadian postmenopausal women. It is a systemic disease characterized by low bone mass and deterioration of bone microarchitecture, resulting in bone fragility and an increased risk of fractures. One in six women over the age of 50 have osteoporosis. The lifetime risk of an osteoporotic fracture for an average 50 year-old Canadian woman is >40%. The annual health care costs for osteoporotic fractures in Canada have been estimated to exceed $1.3 billion. Recent data suggest that vitamin K supplements may decrease bone loss and prevent fractures. Vitamin K is a co-factor of gamma-glutamyl carboxylase, an enzyme that catalyzes the gamma-carboxylation of glutamic acid residues in bone matrix proteins such as osteocalcin. Vitamin K has been reported to enhance bone formation in both in vitro studies and in vivo studies in animals. Vitamin K levels are low in individuals with osteoporosis and in patients with osteoporotic fractures. The few studies examining vitamin K supplementation in humans have showed promising results with no significant side effects, but these studies had significant methodological shortcomings such as inadequate sample size and lack of randomization. The primary objective of our study is to examine whether vitamin K supplementation will increase bone mineral density in postmenopausal women with osteopenia. Our secondary objectives are to examine the possible adverse effects from long-term vitamin K supplementation, to investigate whether vitamin K will decrease risk of fractures and to determine if vitamin K affects quality of life. Our hypotheses are that vitamin K increases bone mineral density in postmenopausal women, and that there are no significant adverse effects from vitamin K supplementation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Menopausal Osteoporosis, Post-Menopausal Osteopenia
Keywords
vitamin K, bone mineral density, post-menopausal women, randomized double blind placebo controlled trial, osteoporosis, women's health

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
440 (Actual)

8. Arms, Groups, and Interventions

Arm Title
phyloquinone
Arm Type
Experimental
Arm Description
5 mg Vitamin K1
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin K1 (phylloquinone)
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
1 pill daily
Primary Outcome Measure Information:
Title
Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms.
Description
BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer
Time Frame
0 to 24 months
Title
Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms.
Description
BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer
Time Frame
0 to 24 months
Secondary Outcome Measure Information:
Title
Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms.
Description
BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer
Time Frame
0 to 24 months
Title
Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms.
Description
BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer
Time Frame
0 to 24 months
Title
Effect of Vitamin K1 Supplementation on Levels of Bone Formation Marker
Description
measured by osteocalcin on elecsys platform
Time Frame
0-24 months
Title
Effect of Vitamin K1 Supplementation on Level of Bone Resorption Markers (C-telopeptide: CTX)
Description
measured by CTX Elisa assay on elecsys platform
Time Frame
0-24 months
Title
Effect of Vitamin K1 Supplementation on Percent of Carboxylation of Osteocalcin
Description
measured by osteocalcin hydroxyapatite binding assay
Time Frame
0 to 24 months
Title
Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms.
Description
BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer
Time Frame
0 to 48 months
Title
Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms.
Description
BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer
Time Frame
0 to 48 months
Title
Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms.
Description
BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer
Time Frame
0 to 48 months
Title
Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms.
Description
BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer
Time Frame
0 to 48 months
Title
Difference in Serious Adverse Events
Description
These include hospitalizations for pneumonia, heart failure, gastro-intestinal bleeding, elective and non-elective surgery, cancer and death.
Time Frame
up to 48 months
Title
Difference in Number of New Cancers by Treatment Arm.
Time Frame
up to 48 months
Title
Difference in Number of New Clinical Fractures by Treatment Arm.
Description
these included fragility fractures
Time Frame
up to 48 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Postmenopausal: One year since the natural cessation of menses, or Hysterectomy with either postmenopausal status confirmed by FSH lab values, or age 55 and above AND 2. Osteopenic: T-score at baseline has to be between (and including) -1.0 and -2.0 in the lumbar spine (L1-L4), total hip or femoral neck, and the lowest reading of the above three measurements must be between -1.0 and -2.0 Exclusion Criteria: Women ever having had a fragility fracture after age 40; Women currently on anticoagulants, previously on anticoagulants in the past 3 months, or expected to be on anticoagulants in the near future; Women on hormone replacement therapy, raloxifene, bisphosphonates or calcitonin during the past 3 months; Women who have ever been on a bisphosphonate for more than 6 months; Women previously diagnosed with Paget's disease, hyperparathyroidism, hyperthyroidism or other metabolic bone diseases; Women with decompensated diseases of the liver, kidney, pancreas, lung, or heart; Women with a history of active cancer in the past 5 years; Women taking mega-doses of vitamin A (more than 10,000 iu per day) or E (more than 400 iu per day); Women involved in other clinical trials; Any women who, in the opinion of the principal investigator, is at poor medical or psychiatric risk for the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela M Cheung, MD, PhD
Organizational Affiliation
University Health Network, University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital Health Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2T2
Country
Canada
Facility Name
Mt. Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
University Health Network, Osteoporosis Department
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Sunnybrook & Women's College Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada
Facility Name
University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 3E2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18922041
Citation
Cheung AM, Tile L, Lee Y, Tomlinson G, Hawker G, Scher J, Hu H, Vieth R, Thompson L, Jamal S, Josse R. Vitamin K supplementation in postmenopausal women with osteopenia (ECKO trial): a randomized controlled trial. PLoS Med. 2008 Oct 14;5(10):e196. doi: 10.1371/journal.pmed.0050196. Erratum In: PLoS Med. 2008 Dec;5(12):e247.
Results Reference
result

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Vitamin K Supplementation in Post-Menopausal Osteopenia

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