ACTRN12607000128493已完成2 期
A randomized, double-blind, placebo-controlled, dose-finding study of the effects of sodium fluoride on bone turnover, bone density and bone histology in osteopenic post menopausal women.
Associate Professor Andrew Grey0 个研究点目标入组 180 人开始时间: 2007年2月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
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
- 45 Years 至 ot stated（—）
- 性别
- Female
入选标准
- •Postmenopausal 5 yrs or more (menopause defined as at least 12 months since last period in woman aged > 45 yrs with intact uterus, or serum follicle stimluating hormone (FSH) > 50 IU/l in younger or hysterectomized woman)- Bone density T score less than -1.0 and greater than -2.5 at L1-L4 or Total Hip.- BMD T-score <-2.5 at lumbar spine or total hip, but participant is not a suitable candidate for, or has decided against taking, osteoporosis therapy
排除标准
- •Medical Conditions- renal impairment (serum creatinine 120 µmol/L).- congestive heart failure- chronic liver disease.- untreated hypothyroidism or hyperthyroidism.- concurrent major systemic illness, including malignancy.- active major gastrointestinal disease.- metabolic bone diseases, or serum alkaline phosphatase (ALP) > 2x normal limit.- primary hyperparathyroidism. - Vitamin D insufficiency (25 hydroxyvitamin D [OHD] < 50nmol/L)Medications- use of oral glucocorticoid drugs equivalent to an average dose of prednisone 2.5 mg/day in the preceding 12 months- use of aminobisphosphonates within the past 2 years, or etidronate within the past 1 year- use of hormone replacement therapy within the last 12 months- use of other medication known to cause osteoporosis or interfere with bone metabolism.
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