NCT00548509已完成4 期
Short-Term Menatetrenone Therapy Increases Gamma-Carboxylation Of Osteocalcin With A Moderate Increase Of Bone Turnover In Postmenopausal Osteoporosis: A Randomized Prospective Study
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 4
- 主要终点
- Gamma-carboxylation
研究概览
简要总结
To investigate the effect of menatetrenone on bone turnover in postmenopausal patients with osteoporosis. One month of menatetrenone therapy enhanced the secretion and gamma-carboxylation of osteocalcin. Moderate increases of bone resorption and formation markers were observed after 6 months. These changes may contribute to fracture prevention in patients with osteoporosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 49 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of osteoporosis was made according to the Year 2000 version of the Diagnostic Criteria for Osteoporosis proposed by the Japanese Society for Bone and Mineral Research.
- •These criteria state that patients with a lumbar bone mineral density (BMD)<70% of the young adult mean or patients with pre-existing osteoporotic fractures and a lumbar BMD<80% of the young adult mean can be diagnosed as having osteoporosis.
排除标准
- •Patients with secondary osteoporosis (e.g., due to major gastrointestinal surgery, steroid therapy, rheumatoid arthritis, premenopausal bilateral oophorectomy, renal dysfunction, and thyroid dysfunction ).
- •Patients taking medications that could affect bone turnover (such as bisphosphonates, estrogen, calcitonin, SERM, active vitamin D3, or Warfarin) were excluded.
结局指标
主要结局
Gamma-carboxylation
次要结局
- Bone turnover marker
研究者
研究点 (4)
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