Evaluation of the Clinical use of vitamin K supplementation in post-menopausal women with Osteopenia

Not Applicable

Completed

Conditions: Osteopenia/osteoporosis
Musculoskeletal Diseases

Registration Number: ISRCTN61708241

Lead Sponsor: niversity Health Network, Toronto (Canada)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 440

Inclusion Criteria

1. Post-menopausal women with osteopenia
2. Lowest bone mineral density at the total hip, femoral neck and lumbar spine (L1 - L4) between -1.0 and -2.0
3. Post-menopausal defined as one year since the natural cessation of menses, or hysterectomy with either post-menopausal status confirmed by follicle stimulating hormone (FSH) laboratory values, or age 55 and above
4. Osteopenic T-score between -1 and -2 on lumbar, total hip or femoral neck bone mineral density (BMD) measurement. Based on documented BMD done within the past 6 months or BMD measurement done at screening.

Exclusion Criteria

1. Women ever having had a fragility fracture after the age of 40
2. Women currently on anticoagulants, previously on anticoagulants in the past 3 months, or expected to be on anticoagulants in the near future
3. Women on hormone replacement therapy, raloxifene, bisphosphonates or calcitonin during the past 3 months
4. Women who have ever been on a bisphosphonate for more than 6 months
5. Women previously diagnosed with Paget?s disease, hyperparathyroidism, hyperthyroidism or other metabolic bone diseases
6. Women with decompensated diseased of the liver, kidney, pancreas, lung or heart; Women with a history of active cancer within the past 5 years
7. Women taking mega-doses of vitamin A (more than 10,000 IU per day) or E (more than 400 IU per day)
8. Women involved in other clinical trials
9. Poor medical or psychiatric risk for the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in the percent change in Bone Mineral Density at the spine (L1 - L4) and the total hip between treatment and placebo groups measured yearly

Secondary Outcome Measures

Name	Time	Method
1. Determining potential adverse effects from long-term vitamin K1 supplementation<br>2. Whether vitamin K1 supplementation affects levels of bone formation markers (serum osteocalcin [OC] and serum bone specific alkaline phosphatase [BAP]) and bone resorption markers (serum N-telopeptide [NTx])<br>3. Whether vitamin K1 supplementation affects the degree of carboxylation of OC, a major vitamin K-dependent protein in bone<br>4. Whether vitamin K1 supplementation affects health-related quality of life<br>5. Whether vitamin K1 supplementation decreases risk of having fragility fractures<br>6. Whether Apo E modulates the effect of vitamin K1 on bone