Nitrates and Bone Turnover (NABT): Trial to Select the Best Nitrate Preparation

University of Toronto1 个研究点分布在 1 个国家目标入组 265 人开始时间: 2011年9月最近更新: 2015年5月8日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: University of Toronto
入组人数: 265
试验地点: 1
主要终点: Bone Turnover Markers

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Purpose: NABT: To compare five widely available nitrate formulations: (1) 15 of nitroglycerin (NTG) ointment, (2) 0.3 mg and (3) 0.6 mg of sublingual NTG, (4) 20 mg of isosorbide mononitrate (an oral tablet), and (5) 160 mg of glycerol trinitrate (a patch), for their efficacy on markers of bone formation and resorption and for the incidence and severity of headache they cause.

Hypothesis: There is one ideal nitrate preparation which balances the clinical efficacy in bone remodeling against the common side effect of headache.

NABT-B: To determine if nitrates affect markers of bone formation (serum BALP and P1NP) and resorption (serum CTX and urine NTX) in women who have recently discontinued treatment with alendronate, risedronate or zoledronate.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

入排标准

年龄范围: 50 Years 至 —（Adult, Older Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Women aged 50 years and older whose last menstrual period occurred at least 3 years ago
•Women without a uterus will be eligible after age 55
•Women aged 50 years and older whose last menstrual period occurred at least 3 years ago
•Women without a uterus will be eligible after age 55
•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.

排除标准

•A previous fracture of the hip, wrist, spine or ankle within the last 3 months; or a diagnosis of osteoporosis;
•A history of bone disorders such as hyperparathyroidism or Paget's disease;
•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);
•Treatment with any antiresorptive agent, including alendronate, risedronate, etidronate or denosumab use for at least four weeks within the last three years;
•Previous treatment with intravenous zoledronate or parathyroid hormone;
•Current treatment with nitrates;
•A history of migraine headaches;
•A history of angina or cardiovascular disease;
•Inability to give informed consent;
•Hypersensitivity to nitroglycerin.
•A previous fracture of the hip, wrist, spine or ankle; or a self-reported diagnosis of osteoporosis;
•A history of bone disorders such as hyperparathyroidism or Paget's disease;
•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);
•Treatment with etidronate or denosumab use for at least four weeks within the last three years and any previous treatment with parathyroid hormone;
•Current treatment with nitrates;
•A history of migraine headaches;
•A history of angina or cardiovascular disease;
•Inability to give informed consent;
•Hypersensitivity to nitroglycerin.

研究组 & 干预措施

Placebo

Placebo Comparator

Placebo Ointment

干预措施: Placebo (Other)