ACTRN12615001027505已完成4 期
Efficacy of nitrates on bone mineral density in postmenopausal women with osteopenia
niversity of Auckland0 个研究点目标入组 240 人开始时间: 2015年10月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 55 Years 至 o limit(—)
- 性别
- Female
入选标准
- •1. Postmenopausal women aged >55 years
- •2. Bone mineral density T score at the lumbar spine, femoral neck or total hip between -1 and -2.5
排除标准
- •1. Bone mineral density T score <-2.5 at the total hip, femoral neck or lumbar spine
- •2. Current use of nitrate agents, or phosphodiesterase-5 inhibitors
- •3. Concurrent major systemic illness including untreated hypothyroidism or hyperthyroidism, chronic liver disease, chronic renal failure, malignancy, and active major gastrointestinal disease
- •4. Known congenital heart disease or hypotension, systolic blood pressure < 100 mmHg
- •5. Metabolic bone disease
- •6. Previous fragility fracture of the hip or clinical spine fracture
- •7. Current or past use of bisphosphonate therapy within 12 months, or any past zoledronate use
- •8. Use of oral glucocorticoid drugs equivalent to an average dose of at least prednisone 2.5mg/day during the preceding 6 months
- •9. Use of hormone replacement therapy within 12 months
- •10. Known nitrate hypersensitivity
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