Post-Menopausal OsteoporosisPhase 3NCT00150969
Vitamin K Supplementation in Post-Menopausal Osteopenia
A Phase 3 study testing vitamin K1 (phylloquinone) in people with Post-Menopausal Osteoporosis and Post-Menopausal Osteopenia, run by University Health Network, Toronto at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-Menopausal Osteoporosis, Post-Menopausal Osteopenia
- What is being tested?
- vitamin K1 (phylloquinone)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 5 sitesCanada
- Study dates
- Jan 2002to Sep 2007
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
St. Michael's Hospital Health Centre
Toronto, Ontario, M5C 2T2
Mt. Sinai Hospital
Toronto, Ontario, M5G 1X5
University Health Network, Osteoporosis Department
Toronto, Ontario, M5G 2C4
Sunnybrook & Women's College Health Sciences Centre
Toronto, Ontario, M5S 1B2
University of Toronto
Toronto, Ontario, M5S 3E2
About this study
Official title: Evaluation of the Clinical Use of Vitamin K Supplementation in Post-Menopausal Women With Osteopenia (ECKO Trial)
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.
Read the 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.
- Being tested
- vitamin K1 (phylloquinone), placebo
- Keywords
- vitamin K, bone mineral density, post-menopausal women, randomized double blind placebo controlled trial, osteoporosis, women's health
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin K1 (phylloquinone)Dietary supplement
placeboDietary supplement
1 pill daily
| Study group | Role | What they receive |
|---|---|---|
| phyloquinone | Experimental | 5 mg Vitamin K1 Receives: Dietary Supplement: vitamin K1 (phylloquinone) |
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 to 24 months
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
Measured: 0 to 24 months
Secondary outcomes (12)
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
Measured: 0 to 24 months
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
Measured: 0 to 24 months
Effect of Vitamin K1 Supplementation on Levels of Bone Formation Marker
measured by osteocalcin on elecsys platform
Measured: 0-24 months
Effect of Vitamin K1 Supplementation on Level of Bone Resorption Markers (C-telopeptide: CTX)
measured by CTX Elisa assay on elecsys platform
Measured: 0-24 months
Effect of Vitamin K1 Supplementation on Percent of Carboxylation of Osteocalcin
measured by osteocalcin hydroxyapatite binding assay
Measured: 0 to 24 months
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
Measured: 0 to 48 months
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
Measured: 0 to 48 months
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
Measured: 0 to 48 months
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
Measured: 0 to 48 months
Difference in Serious Adverse Events
These include hospitalizations for pneumonia, heart failure, gastro-intestinal bleeding, elective and non-elective surgery, cancer and death.
Measured: up to 48 months
Difference in Number of New Cancers by Treatment Arm.
Measured: up to 48 months
Difference in Number of New Clinical Fractures by Treatment Arm.
these included fragility fractures
Measured: up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJan 2002
- Primary completionSep 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Menopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Angela M Cheung, MD, PhD, Principal investigator, University Health Network, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150969
- Sponsor's protocol ID
- 01-0169
- Other IDs
- 50422
- Status last verified
- Dec 2023
- First submitted
- 6 Sep 2005
- Last updated
- 28 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18922041