NCT00004650已完成3 期
Phase III Randomized Study of the Effect of Postmenopausal Estrogen Replacement Therapy on Alveolar Bone Loss
National Institute of Dental and Craniofacial Research (NIDCR)0 个研究点目标入组 150 人开始时间: 1993年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
OBJECTIVES: I. Quantify periodontal alveolar bone loss rates in postmenopausal women.
II. Evaluate the effects of estrogen on alveolar bone loss rates in these patients.
III. Determine whether changes in periodontal bone mass relate to bone mass changes in other skeletal sites in these patients.
详细描述
PROTOCOL OUTLINE: This is a randomized, double-blind, placebo controlled study. Patients are randomly assigned to receive placebo or conjugated estrogens and, if no prior hysterectomy, medroxyprogesterone. Patients also receive calcium supplementation therapy daily for 3 years.
Participants in the placebo group may be removed from study if bone loss exceeds 5% per year.
A study duration of 3 years is anticipated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •Women postmenopausal for at least 2 years
- •At least 10 teeth for which radiographic measurements can be obtained, i.e.: Not severely tilted Not so closely spaced that interproximal bone is thin Not in positions of restricted access
排除标准
- 未提供
研究者
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