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临床试验/NCT00460057
NCT00460057已完成4 期

The Change of Bone Markers After Low Dose Alendronate in Postmenopausal Women

Eulji University Hospital0 个研究点目标入组 63 人开始时间: 2006年3月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
63
主要终点
Changes of bone turnover markers

研究概览

简要总结

High bone turnover with the bone resorption exceeding bone formation is a major mechanism of postmenopausal osteoporosis. Therefore, inhibition of bone resorption is a rational approach for the prevention. The Objective of the current study was to determine the short-term efficacy of once-weekly low dose alendronate in the prevention of bone loss in early postmenopausal Korean women with moderate bone loss via bone turnover markers.

This study was a 12-week, randomized, double-blind clinical trial compared the effects of placebo with alendronate 20 mg once weekly. All subjects received supplemental calcium 600 mg and vitamin D 400 IU daily. Fifty two postmenopausal women (the ages between 50-65 year) with lumbar spine BMD at least 2.0 SD below the peak young adult mean were recruited at Eulji University Hospital, Daejeon, Korea. BMD was measured by DXA at baseline and serum alkaline phosphatase, osteocalcin and C-terminal telopeptide of type I collagen was measured at baseline and 12 weeks after treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • postmenopausal women (the ages between 50-65 year) with lumbar spine BMD at least 2.0 SD below the peak young adult mean

排除标准

  • severe osteoporosis
  • current medication of osteoposis
  • metabolic bone disease
  • cancer, stroke etc.

研究组 & 干预措施

Alendronate, Placebo

Placebo Comparator

All subjects were given 600 mg of calcium and 400 IU of vitamin D supplements. The subjects were randomized to receive weekly alendronate 20 mg (n = 31) or placebo (n = 32).

干预措施: Alendronate (Drug)

结局指标

主要结局

Changes of bone turnover markers

时间窗: 12 weeks

to determine the short-term efficacy of once-weekly low-dose alendronate, via bone turnover markers and OPG, in the prevention of bone loss in early postmenopausal Korean women with moderate bone loss.

次要结局

未报告次要终点

研究者

发起方
Eulji University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hee-Jeong Choi

Associate Professor

Eulji University Hospital

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