ISRCTN08860742已完成3 期
itrates and Bone Turnover: A randomised controlled trial to select the best nitrate preparation
Women's College Research Institute (Canada)0 个研究点目标入组 210 人开始时间: 2011年7月27日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
研究概览
简要总结
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24010992
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current inclusion criteria as of 10/01/2013:
- •1. Women aged 50 years and older whose last menstrual period occurred at least 3 years ago
- •2. Women without a uterus will be eligible after age 55
- •3. Women previously treated with alendronate but stopped within 2 years of study commencement; or previously treated with risedronate but stopped within 1 year of study commencement; or previously treated with zoledronate (NABT-B only)
- •Previous inclusion criteria until 10/01/2013:
- •1. Women aged 50 years and older whose last menstrual period occurred at least 3 years ago
- •2. Women without a uterus will be eligible after age 55
排除标准
- •Current exclusion criteria as of 10/01/2013:
- •1. Previous fracture of the hip, wrist, spine or ankle
- •2. Diagnosis of Osteoporosis (NABT main study only)
- •3. History of bone disorders such as hyperparathyroidism or Paget?s disease
- •4. Treatment within 12 months of study entry with any agent that may influence bone metabolism including any hormone, anti-estrogen or raloxifene and prednisone (equivalent to 5 mg/d for 12 months or greater)
- •5. Treatment with any antiresorptive agent, including alendronate, risedronate, use for at least four weeks, within the last three years and any previous treatment with intravenous zoledronate (NABT only)
- •6. Treatment with etidronate or denosumab use for at least four weeks, within the last three years and any previous treatment with parathyroid hormone
- •7. Current treatment with nitrates
- •8. Any history of migraine headaches (nitrates can exacerbate migraines)
- •9. History of angina or cardiovascular disease
- •10. Inability to give informed consent
- •11. Hypersensitivity to nitroglycerin
- •12. Allergies to the adhesive used in nitroglycerin patches
- •13. Acute circulatory failure associated with marked hypotension (shock and states of collapse)
- •14. Postural hypotension
- •15. Increased intracranial pressure
- •16. Increased intraocular pressure
- •17. Severe anemia.
- •Previous exclusion criteria until 10/01/2013:
- •1. Previous fracture of the hip, wrist, spine or ankle, or those who report a diagnosis of osteoporosis, (?osteopenia? will not be excluded)
- •2. History of bone disorders such as hyperparathyroidism or Paget?s disease
- •3. Treatment within 12 months of study entry with any agent that may influence bone metabolism including any hormone, anti-estrogen or raloxifene and prednisone (equivalent to 5 mg/d for 12 months or greater)
- •4. Treatment with an antiresorptive agent, including alendronate, risedronate, etidronate or denosumab use for at least four weeks, within the last three years
- •5. Any previous treatment with intravenous zoledronate or parathyroid hormone
- •6. Current treatment with nitrates
- •7. Any history of migraine headaches (nitrates can exacerbate migraines)
- •8. History of angina or cardiovascular disease
- •9. Inability to give informed consent
- •10. Hypersensitivity to nitroglycerin
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