ISRCTN61708241已完成未知
Evaluation of the clinical use of vitamin K supplementation in post-menopausal women with osteopenia: a randomised controlled trial
niversity Health Network, Toronto (Canada)0 个研究点目标入组 440 人开始时间: 2005年9月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 440
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •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.
排除标准
- •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
研究者
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