EUCTR2006-006086-16-SE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. - MALEO
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 lower than or equal to 0.840g/cm² or femoral neck BMD lower than or equal to 0.600g/cm² measured by Hologic apparatus
- •- Mean lumbar spine BMD lower than or equal to 0.949g/cm² or femoral neck BMD lower than or equal to 0.743 g/cm² measured by Lunar apparatus
- •. 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) yes
- •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 fractures
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）
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 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-EEInstitut 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