A Randomized, Double-Blind, Multicenter, Parallel Pilot Clinical Trial to Study the Efficay of a Treatment of Lactulose + Vitamin D + Calcium 0.5 g Concurrently Controlled With a Standard Treatment (Vit D + Calcium) in Bone Mass Preservation Among Postmenopausal Women

Solvay Pharmaceuticals3 个研究点分布在 1 个国家目标入组 40 人开始时间: 2003年1月最近更新: 2009年1月30日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Solvay Pharmaceuticals
入组人数: 40
试验地点: 3
主要终点: bone mass preservation by bone densitometry values in 1 year period

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a randomized, double-blind, multicentre, parallel pilot clinical trial to study the efficacy of a treatment of lactulose 15 ml + vitamin D 400 U + calcium 0.5 g compared to lactulose placebo 15 ml + vitamin D 400 U + calcium 1 g in bone mass preservation among postmenopausal women.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
盲法: Double

入排标准

年龄范围: 55 Years 至 65 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Women aged between 55 and 65 years old; postmenopausal who have amenorrhea for 5 or more years; women with the diagnosis of osteopenia defined DMO -1,5 to -2,5

排除标准

•Any disease causing osteopenia (hyperthyroidism, hyperparathyroidism, hypercortisolism, osteogenesis imperfecta, rheumatoid arthritis, homocystinuria, etc.)

结局指标

主要结局

bone mass preservation by bone densitometry values in 1 year period

次要结局

evolution of bone remodelling parameters

研究者

发起方

Solvay Pharmaceuticals

申办方类型

Industry

研究点 (3)

Loading locations...

相似试验

已完成

3 期

An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) TherapyRheumatoid Arthritis

NCT03155347Hoffmann-La Roche340

已完成

3 期

A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate TherapyRheumatoid Arthritis

NCT01895309Samsung Bioepis Co., Ltd.596

已完成

3 期

A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate TherapyRheumatoid Arthritis

NCT01936181Samsung Bioepis Co., Ltd.584

已完成

3 期

A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate TherapyRheumatoid Arthritis

NCT02167139Samsung Bioepis Co., Ltd.544

已完成

3 期

Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)COPD

NCT02465567Pearl Therapeutics, Inc.8,588