ISRCTN57103074已完成不适用
Effect on bone turnover and Bone Mineral Density (BMD) of low dose oral silicon as an adjunct to calcium/vitamin D3 in a randomised, placebo-controlled trial
Bio Minerals N.V. (Belgium)0 个研究点目标入组 184 人开始时间: 2008年1月7日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 184
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Osteopenic, but otherwise healthy
- •2. Caucasian women with a T-score less than -1.5 at the lumbar spine by Dual Energy X-ray Absorptiometry (DEXA) scan
- •3. Age range: mean age of 60.7 ± 10.4 years; gender of participants: female
排除标准
- •Patients were excluded according to the following criteria:
- •1. Renal failure as defined by serum creatinine greater than 200 µmol/L
- •2. Abnormal serum ferritin level (normal range: 11 - 250 µg/L)
- •3. Concomitant medication (treatment with phosphate-binding antacids greater than 6 months/year)
- •4. Oral glucocorticoid treatment (greater than 8 months in the previous year and greater than 7.5 mg/day prednisone equivalent, or a total dose of more than 2 g prednisone equivalent in the previous 12 months)
- •5. Local injectable glucocorticoid treatment if greater than 5 injections per year
- •6. Inhaled glucocorticoid treatment if greater than 6 months in the previous year and more than 2 mg/day prednisone equivalent (glucocorticoids by local topical administration were not excluded)
- •7. Concomitant or previous treatment for bone diseases:
- •7.1. Fluoride salts: greater than 10 mg/day, for more than 2 weeks in the previous 12 months
- •7.2. Biphosphanates: for more than 2 weeks in the previous 12 months
- •7.3. Oral estrogens
- •7.4. Estradiol vaginal ring
- •7.5. Anti-estrogens
- •7.6. Progesterones
- •7.7. Anabolic steroids in the previous 3 months or used for more than 1 month in the previous 6 months
- •7.8. Estradiol implants in the previous 3 years
- •7.9. Ipriflavone use in the previous 6 months or used for more than 1 month in the previous 12 months
- •7.10. Calcitonin use in the previous month or used for more than 1 month in the previous 6 months
- •8. Other drugs for bone disease currently in development
- •9. Concomitant and previous use of food supplements containing silicon or horsetail herb extract, bamboo extract, colloidal silicic acid, or silanol derivatives in the previous 6 months
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