EUCTR2006-004717-17-EE进行中（未招募）不适用
The efficacy and safety of 2g strontium ranelate in the treatment of osteoporosis in men. A prospective multicentre, international, double-blind, placebo-controlled study with a treatment duration of 2 years and the main study analysis after 1 year.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 221
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
- 性别
- Male
入选标准
- •· The following BMD criterion:
- •Mean lumbar spine BMD or femoral neck BMD or total femur BMD corresponding to a T-score lower than –2.5SD of the young healthy male reference population
- •Mean lumbar spine BMD or femoral neck BMD or total femur BMD corresponding to a T-score lower than –1.5SD of the young healthy male reference population plus a prevalent low impact fracture during adulthood
- •· Caucasian males of at least 65 years of age (with no upper age limit)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •· Bone mineral density T-score below –4.0 at one or more of the measured sites
- •· More than two prevalent mild and/or moderate osteoporotic vertebral fractures
- •· Severe osteoporotic vertebral fracture
- •. Other criteria (detailed in the protocol)
研究者
相似试验
进行中（未招募）
不适用
The efficacy and safety of 2g strontium ranelate in the treatment of male osteoporosis.A prospective multicentre, international, double-blind, placebo-controlled study with a treatment duration of 2 years and the main study analysis after 1 year. - MALEOmale osteoporosisMedDRA version: 9.1Level: PTClassification code 10031282Term: OsteoporosisEUCTR2006-006086-16-BEInstitut de Recherches Internationales Servier221
进行中（未招募）
不适用
The efficacy and safety of 2g strontium ranelate in the treatment of male osteoporosis.A prospective multicentre, international, double-blind, placebo-controlled study with a treatment duration of 2 years and the main study analysis after 1 year. - MALEOmale osteoporosisMedDRA version: 9.1Level: PTClassification code 10031282Term: OsteoporosisEUCTR2006-006086-16-SEInstitut de Recherches Internationales Servier221
进行中（未招募）
1 期
The efficacy and safety of 2g strontium ranelate in the treatment of osteoporosis in men. A prospective multicentre, international, double-blind, placebo-controlled study with a treatment duration of 2 years and the main study analysis after 1 year.Osteoporosis in menMedDRA version: 9.1Level: PTClassification code 10031282Term: OsteoporosisEUCTR2006-004717-17-CZInstitut de Recherches Internationales Servier221
进行中（未招募）
不适用
The efficacy and safety of 2g strontium ranelate in the treatment of male osteoporosis.A prospective multicentre, international, double-blind, placebo-controlled study with a treatment duration of 2 years and the main study analysis after 1 year.Eficacia y seguridad de 2 g de ranelato de estroncio en el tratamiento de la osteoporosis en hombre. Estudio prospectivo, multicéntrico, internacional, doble ciego, controlado frente a placebo con una duración del tratamiento de 2 años y el análisis principal del estudio tras 1 año. - MALEOmale osteoporosisMedDRA version: 9.1Level: PTClassification code 10031282Term: OsteoporosisEUCTR2006-006086-16-ESaboratorios Servier S.L.221
进行中（未招募）
不适用
The efficacy and safety of 2g strontium ranelate in the treatment of male osteoporosis.A prospective multicentre, international, double-blind, placebo-controlled study with a treatment duration of 2 years and the main study analysis after 1 year. - MALEOmale osteoporosisMedDRA version: 9.1Level: PTClassification code 10031282Term: OsteoporosisEUCTR2006-006086-16-IEInstitut de Recherches Internationales Servier221