EUCTR2015-001059-63-DK进行中（未招募）1 期
BONATHIAD - Bone Association with Thiazide Diuretics. - BONATHIAD
Aalborg University0 个研究点目标入组 175 人开始时间: 2015年3月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 175
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Females above the age of 50 and below the age of 85 years of age.
- •Caucasian ethnicity.
- •Menopause for at least two years.
- •Referred to a DXA-scan at the Osteoporosis Clinic at the Department of
- •Endocrinology, Aalborg University Hospital.
- •T-score = -2,5 in total lumbar spine, hip region or femoral neck
- •Prescribed oral alendronic acid of a dose of 70 mg weekly with
- •supplement of Calcum and colecalciferol
- •Appropriate birth control for fertile women as outlined in protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 87
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 87
排除标准
- •Prior traumatic fracture of spine or hip assessed by X-ray or >20%
- •compression fracture assessed by VFA.
- •BMI < 17 og > 30.
- •Prior or current anabolic or antiresorptive osteoporosis treatment other
- •than bisphosphonates after diagnosis.
- •Prior or current use of anticonvulsives, lithium, prednisolon.
- •Prior or current use of thiazides as monotherapy or combination therapy for the previous 5 years
- •Secondary osteoporosis assessed by investigator.
- •Primary bone disease assessed by investigator
- •Renal failure, eGFR < 50 mmol/L/1,73m2.
- •Inability to participate, complete trial or comprehend information as
- •assessed by investigator.
- •Moderate hyponatremia, [Na+] < 130 mmol/L
- •Hypercalcemia, [Ca2+]-albumin adjusted > 2,7 mmol/L
研究者
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