The effect of organic nitrates on osteoporosis: a randomised controlled trial

Women?s College Hospital (Canada)0 个研究点目标入组 280 人开始时间: 2005年11月18日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Prior low trauma hip or vertebral fracture; these subjects have OP and require treatment
•2. Total hip or femoral neck T score of less than -2.0; these subjects either have OP and require treatment, or are at increased risk of developing OP over the course of the main study
•3. Bone disorders other than osteopenia (e.g. hyperparathyroidism or Paget?s disease); these subjects require treatment
•4. Treatment within six months of study entry with androgen, calcitonin, oestrogen, progesterone, fluoride in a tablet form, raloxifene, tamoxifen, etidronate, prednisone or an equivalent at 5 mg/day for 12 months or greater, lithium or anticonvulsants. These agents can alter levels of bone turnover markers for up to six months.
•5. Alendronate or risedronate use for at least four weeks, within the last three years. These agents may influence bone remodeling for up to three years.
•6. Current treatment with nitrates
•7. Systolic blood pressure of less than 100 mmHg or diastolic blood pressure greater than 110 mmHg at the baseline screening examination
•8. Abnormal electrocardiogram (ECG) at the baseline screening examination
•9. History of myocardial infarction, angina, valvular or congenital heart disease
•10. Disabling conditions that may interfere with follow-up visits
•11. Inability to give informed consent
•12. Migraine headaches; nitrates can exacerbate migraines
•13. Hypersensitivity to nitrates

发起方

Women?s College Hospital (Canada)